Chrysalis Intelligence · Sponsors · Bard Peripheral Vascular, Inc.

Bard Peripheral Vascular, Inc.

Tempe, AZ, US · 13 510(k) clearances · 44 PMAs · 47 recalls (1 Class I)

Total clearances
13
2021-06-04 → 2026-08-14
Last 12 months
3
Product codes
9
Most recent
2026-08-14
Name variants in FDA filings: Bard Peripheral Vascular / Bard Peripheral Vascular, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KNW Instrument, Biopsy Class II Gastroenterology, Urology 5 2026-08-14
PNO Catheter, Percutaneous, Cutting/Scoring Class II Cardiovascular 1 2026-02-04
DQY 1 2025-06-17
NEU Marker, Radiographic, Implantable Class II General, Plastic Surgery 1 2025-03-24
MCW Catheter, Peripheral, Atherectomy Class II Cardiovascular 1 2025-01-30
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Class II Gastroenterology, Urology 1 2024-12-06
LJT 1 2023-12-08
DYB Introducer, Catheter Class II Cardiovascular 1 2022-05-31
MSD Catheter, Hemodialysis, Implanted Class II Gastroenterology, Urology 1 2021-06-04
Class III

PMA approvals (44)

Total PMA records
44
Originals + supplements
Distinct product codes
5
First decision
2020-04-30
Most recent
2026-06-22
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-22 P130029-S015 Fluency™ Plus Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2026-06-10 P180037-S015 Venovo™ Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2026-06-10 P130029-S014 Bard™ Fluency™ Plus Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2026-06-10 P070014-S069 LifeStent™ 5F Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-05-15 P070014-S068 LifeStent 5F Vascular Stent System Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2026-03-10 P070014-S067 LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2025-12-16 P070014-S066 LifeStent® Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-09-29 P160024-S014 LifeStream™ Balloon Expandable Vascular Covered Stent 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2025-08-13 P130029-S013 FLUENCY PLUS ENDOVASCULAR STENT GRAFT 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2024-12-06 P180037-S014 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-12-06 P160024-S013 LifeStream Balloon Expandable Vascular Covered Stent 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-07-27 P070014-S065 LifeStent Vascular Stent System Normal 180 Day Track No User Fee NIP Stent, Superficial Femoral Artery Unknown
2023-02-17 P130029-S012 Fluency™ Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-02-02 P180037-S012 Venovo™ Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-02-02 P070014-S064 LifeStent™ 5F Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-08-23 P160024-S012 LifeStream® Balloon Expandable Vascular Covered Stent Normal 180 Day Track No User Fee PRL Iliac Covered Stent, Arterial Unknown
2022-05-26 P080007-S027 Bard E- Luminexx Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2022-05-23 P180037-S011 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2022-05-20 P180037-S010 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2022-04-22 P180037-S009 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2022-02-11 P160024-S011 LifeStream Balloon Expandable Vascular Covered Stent Real-Time Process PRL Iliac Covered Stent, Arterial Unknown
2021-12-16 P180037-S008 Venovo Venous Stent System Real-Time Process QAN Stent, Iliac Vein Unknown
2021-11-23 P130029-S011 Fluency® Plus Endovascular Stent Graft Real-Time Process PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-11-23 P080007-S026 E-Luminexx® Vascular Stent Real-Time Process NIO Stent, Iliac Unknown
2021-11-19 P180037-S007 Venovo Venous Stent System Normal 180 Day Track No User Fee QAN Stent, Iliac Vein Unknown
2021-08-05 P180037-S006 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2021-08-05 P130029-S010 Bard Fluency Plus Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-08-05 P080007-S025 Bard E-Luminexx and LifeStar Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2021-08-05 P070014-S063 LifeStent Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-06-03 P180037-S005 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2021-06-03 P070014-S062 LifeStent 5F Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-05-19 P070014-S060 LifeStent Vascular Stent Systems 135 Review Track For 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-03-23 P130029-S009 Bard Fluency Plus Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-03-23 P080007-S024 Bard E-Luminexx Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2020-10-28 P160024-S010 LifeStream Balloon Expandable Vascular Covered Stent 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2020-10-01 P180037-S004 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2020-09-25 P180037-S003 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2020-09-25 P070014-S061 LifeStent 5F Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-09-24 P160024-S009 LifeStream Balloon Expandable Vascular Covered Stent 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2020-09-09 P180037-S002 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2020-08-20 P180037-S001 Venovo Venous Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2020-05-29 P130029-S008 Bard Fluency Plus Endovascular Stent Graft 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-05-29 P080007-S023 Bard E-Luminexx Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2020-04-30 P160024-S008 LifeStream Balloon Expandable Vascular Covered Stent 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
Safety

Recalls (47)

Class I (serious)
1
Risk of injury / death
Total recalls
47
Currently ongoing
35
Most recent
2025-12-12
DateSeverityStatusRecall # ProductCodeReason
2025-12-12 Class II Ongoing Z-1367-2026 Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 Due to damage to outer tray that can potentially compromise the sterile barrier
2025-11-06 Class II Ongoing Z-0887-2026 Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously s…
2025-08-21 Class II Ongoing Z-2638-2025 Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl… Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in…
2025-02-05 Class I Ongoing Z-1244-2025 Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: … Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer…
2024-09-30 Class II Ongoing Z-0467-2025 Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 … Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the…
2024-09-04 Class II Ongoing Z-0371-2025 The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur… The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of th…
2024-08-02 Class II Ongoing Z-3206-2024 BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Bio… Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be c…
2024-07-10 Class II Ongoing Z-3062-2024 Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu… Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is…
2023-11-14 Class II Ongoing Z-0676-2024 BD Recanalization System, REF: BDRECANSYSTEM Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-mi…
2023-11-08 Class II Ongoing Z-0643-2024 Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G… The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed …
2023-08-10 Class II Ongoing Z-0027-2024 Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohi…
2023-04-11 Class II Ongoing Z-1564-2023 Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle f…
2023-02-28 Class II Ongoing Z-1260-2023 Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirem…
2023-01-04 Class II Ongoing Z-1051-2023 Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter R… Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
2022-12-22 Class II Ongoing Z-1108-2023 The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol… An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
2022-04-22 Class II Ongoing Z-1273-2022 REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following dr…
2022-01-20 Class II Ongoing Z-0800-2022 SAFE-T PLUS ATRAUMATIC ADULT LP TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0799-2022 LUMBAR PUNCTURE DRUG FREE TRAY 22G Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0798-2022 ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0797-2022 SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0796-2022 LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0795-2022 LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0794-2022 SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0793-2022 ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0792-2022 LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0791-2022 LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2022-01-20 Class II Ongoing Z-0790-2022 Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
2021-08-24 Class II Terminated Z-0154-2022 Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single… Due to misbranded products shipped to customers.
2021-08-24 Class II Terminated Z-0153-2022 Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, … Due to misbranded products shipped to customers.
2021-07-27 Class II Ongoing Z-0002-2022 REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 1088… Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
2021-06-23 Class II Ongoing Z-2249-2021 TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration… Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
2021-06-23 Class II Ongoing Z-2248-2021 EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
2021-06-23 Class II Ongoing Z-2247-2021 TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshi… Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
2021-03-25 Class II Terminated Z-1552-2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 58295… Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
2021-03-25 Class II Terminated Z-1551-2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295… Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
2021-03-25 Class II Terminated Z-1550-2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295… Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
2021-01-14 Class II Terminated Z-1289-2021 BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the … Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during …
2020-12-14 Class II Ongoing Z-1899-2021 VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL1406… Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
2020-12-14 Class II Ongoing Z-1898-2021 VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL1006… Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
2020-12-14 Class II Ongoing Z-1897-2021 VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL1606… Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
2020-10-01 Class II Terminated Z-0080-2021 Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usag… Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use…
2020-03-17 Class II Terminated Z-1689-2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Produ… Sterility compromised due to packaging pouches that may not be sealed properly
2020-01-15 Class II Ongoing Z-1964-2020 BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-End… The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
2020-01-03 Class II Terminated Z-1434-2020 Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouche… Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for…
2020-01-03 Class II Terminated Z-1433-2020 Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches… Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for…
2020-01-03 Class II Terminated Z-1432-2020 Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/c… Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for…
2020-01-03 Class II Terminated Z-1431-2020 Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pou… Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for…
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-08-14 K262571 EnCor EnCompass™ Breast Biopsy and Tissue Removal System KNW Class II Gastroenterology, Urology
2026-02-04 K260012 UltraScore™ Focused Force PTA Balloon PNO Class II Cardiovascular
2025-12-12 K252681 EnCor EnCompass™ Breast Biopsy and Tissue Removal System KNW Class II Gastroenterology, Urology
2025-07-10 K250032 Marquee™ Disposable Core Biopsy Instrument and Instrument Kit KNW Class II Gastroenterology, Urology
2025-06-17 K250219 Dorado™ PTA Balloon Dilatation Catheter DQY
2025-03-24 K243642 UltraCor™ Twirl™ Breast Tissue Marker NEU Class II General, Plastic Surgery
2025-01-30 K242757 Rotarex Atherectomy System MCW Class II Cardiovascular
2024-12-06 K241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- PNG Class II Gastroenterology, Urology
2023-12-08 K232737 PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port LJT
2022-05-31 K221440 Liverty™ TIPS Access Set DYB Class II Cardiovascular
2022-03-30 K213896 BD Trek Powered Bone Biopsy System KNW Class II Gastroenterology, Urology
2021-07-15 K211933 EleVation Breast Biopsy System KNW Class II Gastroenterology, Urology
2021-06-04 K211410 GlidePath 13F Long-Term Hemodialysis Catheter MSD Class II Gastroenterology, Urology