Z-2415-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 20, 2020
- Termination Date
- January 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2123 total
Product Description
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
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