| 2025-05-28 |
Class II
|
Ongoing |
Z-2018-2025 |
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Tri… |
— |
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additional… |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1492-2025 |
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 |
— |
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. … |
| 2024-02-20 |
Class II
|
Ongoing |
Z-1401-2024 |
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 6… |
— |
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential my… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1347-2023 |
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC |
— |
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak a… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1346-2023 |
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE |
— |
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak a… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1345-2023 |
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 |
— |
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak a… |
| 2022-02-03 |
Class II
|
Terminated |
Z-0949-2022 |
Cardiovascular Procedure Kit catalog # 76645 & 73806 |
— |
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. |
| 2021-06-08 |
Class II
|
Terminated |
Z-2350-2021 |
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 |
— |
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The cont… |
| 2021-04-16 |
Class II
|
Terminated |
Z-1791-2021 |
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporea… |
— |
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol wi… |
| 2021-04-16 |
Class II
|
Terminated |
Z-1790-2021 |
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchange… |
— |
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol wi… |
| 2021-04-16 |
Class II
|
Terminated |
Z-1789-2021 |
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directl… |
— |
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol wi… |
| 2021-03-02 |
Class II
|
Terminated |
Z-1367-2021 |
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an a… |
— |
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
| 2020-11-11 |
Class II
|
Terminated |
Z-0565-2021 |
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog… |
— |
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) |
| 2020-08-25 |
Class II
|
Terminated |
Z-2961-2020 |
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use… |
— |
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped w… |
| 2020-08-25 |
Class II
|
Terminated |
Z-2960-2020 |
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended… |
— |
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped w… |
| 2020-08-25 |
Class II
|
Terminated |
Z-2959-2020 |
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use… |
— |
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped w… |
| 2020-01-10 |
Class II
|
Terminated |
Z-1111-2020 |
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up… |
— |
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a n… |
| 2020-01-10 |
Class II
|
Terminated |
Z-1110-2020 |
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in … |
— |
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a n… |
| 2020-01-10 |
Class II
|
Terminated |
Z-1109-2020 |
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for … |
— |
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a n… |
| 2020-01-10 |
Class II
|
Terminated |
Z-1108-2020 |
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for … |
— |
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a n… |