Z-2412-2020 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 AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
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 Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W