Chrysalis Intelligence · Sponsors · Atrium Medical Corporation

Atrium Medical Corporation

Merrimack, NH, US · 2 510(k) clearances · 12 PMAs · 89 recalls (2 Class I)

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Total clearances
2
2021-09-03 → 2024-03-28
Last 12 months
0
Product codes
2
Most recent
2024-03-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class II Cardiovascular 1 2024-03-28
CAC Apparatus, Autotransfusion Class II Anesthesiology 1 2021-09-03
Class III

PMA approvals (12)

Total PMA records
12
Originals + supplements
Distinct product codes
1
First decision
2023-03-22
Most recent
2026-05-13
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-13 P120003-S007 iCast Covered Stent System 135 Review Track For 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2025-12-22 P120003-S009 iCast Covered Stent System Normal 180 Day Track PRL Iliac Covered Stent, Arterial Unknown
2025-09-12 P120003-S011 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2025-08-20 P120003-S010 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2025-07-07 P120003-S006 iCast Covered Stent System Normal 180 Day Track PRL Iliac Covered Stent, Arterial Unknown
2025-05-01 P120003-S008 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2024-08-07 P120003-S005 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2024-07-24 P120003-S004 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-10-18 P120003-S003 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-09-12 P120003-S002 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-07-12 P120003-S001 iCast Covered Stent System 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-03-22 P120003 iCast Covered Stent System Original PRL Iliac Covered Stent, Arterial Unknown
Safety

Recalls (89)

Class I (serious)
2
Risk of injury / death
Total recalls
89
Currently ongoing
88
Most recent
2026-08-07
DateSeverityStatusRecall # ProductCodeReason
2026-08-07 Class II Ongoing Z-3113-2026 Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
2026-08-07 Class II Ongoing Z-3112-2026 Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. … — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
2026-08-07 Class II Ongoing Z-3111-2026 Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28F… — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
2024-09-09 Class II Ongoing Z-0024-2025 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 — There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
2024-05-03 Class II Ongoing Z-2018-2024 FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2017-2024 FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2016-2024 FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2015-2024 FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2014-2024 FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2013-2024 FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2012-2024 FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2011-2024 FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2010-2024 FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2009-2024 FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2008-2024 FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2007-2024 FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2006-2024 FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2005-2024 FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2004-2024 FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2003-2024 FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2002-2024 FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2001-2024 ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-2000-2024 ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1999-2024 ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1998-2024 ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1997-2024 ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1996-2024 ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1995-2024 ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1994-2024 ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1993-2024 ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1992-2024 ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1991-2024 ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1990-2024 ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1989-2024 ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1988-2024 ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1987-2024 ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1986-2024 ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1985-2024 ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1984-2024 ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1983-2024 ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1982-2024 ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1981-2024 ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1980-2024 ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1979-2024 ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1978-2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1977-2024 ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1976-2024 ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1975-2024 ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1974-2024 ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1973-2024 ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1972-2024 ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1971-2024 ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1970-2024 ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1969-2024 ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1968-2024 ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1967-2024 ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1966-2024 ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1965-2024 ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1964-2024 ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1963-2024 ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1962-2024 ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1961-2024 ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1960-2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1959-2024 ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1958-2024 ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1957-2024 ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1956-2024 ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1955-2024 ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1954-2024 ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1953-2024 ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1952-2024 ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03 Class II Ongoing Z-1951-2024 ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2023-11-01 Class II Ongoing Z-0621-2024 Atrium Oasis Drain Single W / AC, Part No. 3600-100 — A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming p…
2023-09-29 Class II Ongoing Z-0484-2024 Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. — A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
2023-09-21 Class II Ongoing Z-0291-2024 Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of … — Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
2023-09-18 Class II Ongoing Z-0318-2024 Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU — Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter…
2023-09-18 Class II Ongoing Z-0317-2024 Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI… — Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter…
2023-09-18 Class II Ongoing Z-0316-2024 Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)… — Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter…
2023-09-05 Class II Ongoing Z-0486-2024 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY — Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture…
2023-09-05 Class II Ongoing Z-0485-2024 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION… — Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture…
2023-03-01 Class II Ongoing Z-1303-2023 Express Mini 500 Dry Seal Chest Drain, Part Number 16400 — The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against …
2023-03-01 Class II Ongoing Z-1302-2023 Atrium Pneumostat Chest Drain Valve, Part Number 16100 — The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against …
2022-10-18 Class II Ongoing Z-0235-2023 Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 — Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
2022-04-21 Class II Ongoing Z-1297-2022 Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavi… — Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expirat…
2022-03-03 Class I Ongoing Z-1077-2022 iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 … — Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system w…
2022-03-03 Class I Ongoing Z-1076-2022 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85… — Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system w…
2021-10-22 Class II Ongoing Z-0307-2022 The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chambe… — Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
2021-08-26 Class II Ongoing Z-2592-2021 Atrium Pneumostat Chest Drain Valve, Part Number 16100 — The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant wh…
2021-08-25 Class II Terminated Z-2589-2021 Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vasc… — The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2024-03-28 K231972 Advanta VXT Vascular Graft, Flixene Vascular Graft DSY Class II Cardiovascular
2021-09-03 K201305 Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain CAC Class II Anesthesiology
Data source: openFDA · Generated 2026-09-23 11:01 · Last ingest 2026-09-23T15:00:49.349277 · Pipeline: Chrysalis Intelligence