Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed 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: This is an FDA Class I recall, which mandates a minimum severity of Severe. The affected product is a critical cardiac medical device where short battery run-times present a potential device failure hazard. No illnesses or injuries have been reported.
Plain-English summary
The Arrow AutoCAT2 intra-aortic balloon pump (AEROAUTOCAT2, REF IAP-0435, IPN000312) manufactured by Arrow International Inc. is being recalled worldwide.
The recall addresses a potential issue with short battery run-times on the affected intra-aortic balloon pump devices. These are cardiac medical devices used in clinical settings.
The recall affects 12 units with UDI/DI codes (01) 0 0801902 05174 5 and (01) 0 0801902 05174 6, and applies to all lot and serial numbers. The devices have been distributed worldwide.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 12
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 05174 5
- (01) 0 0801902 05174 6
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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