Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall; the rubric specifies that Class I recalls never go below severity 4. The affected device is a life-critical intra-aortic balloon pump used in cardiac care, and battery run-time deficiency could result in device malfunction. No illnesses or deaths have been reported in the available source material.
Plain-English summary
Arrow International's AutoCAT2 Intra-Aortic Balloon Pump (AC3 IABP NA/AJLA, Model REF IAP-0601) is the subject of a Class I FDA recall due to a potential issue with battery run-times. The recall covers all lot and serial numbers of the device and affects units distributed worldwide.
An intra-aortic balloon pump is a critical device used in cardiac care to support the heart during treatment. The issue identified in this recall concerns the battery run-time on the affected devices, which may be shorter than the manufacturer's specifications.
The FDA has classified this as a Class I recall, indicating potential for serious adverse health consequences or device failure.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- battery-runtime
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI (01) 0 0801902 09118 5
- (01) 0 0801902 09118 6
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
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