FDA Device recall Z-2412-2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
- FDA Device
- Class I
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class I recall of Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I by Arrow International, citing 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 fail….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2412-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-05-20 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
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.
Identifiers
| code_info | Serial Number Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2412-2020%22
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