Device product
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
Z-2415-2020
Product summary
- Event
- Event 85684
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2123 total
- Official record key
device-enforcement:Z-2415-2020
Official wording
Reason: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
Code information: Serial Number Range: AEROAUTOCAT 2 WAVE IAP-0535 150907W 151030W 151101W 151104W 151106W 160305W through 160306W 160743W 160824W 190119W through 190120W 190221W 190223W through 190226W 191047W
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.