FDA Recalls Arrow AutoCAT2WAVE IABP for Short Battery Runtime
The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.
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 score of 4 per the rubric. The potential for short battery run-times on an intra-aortic balloon pump, a life-critical cardiac support device, creates significant risk to patients dependent on mechanical circulatory support.
Plain-English summary
The Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), manufactured by ARROW INTERNATIONAL Inc., is subject to a worldwide recall. This device is used in critical care to support heart function in patients requiring mechanical circulatory support.
The FDA has identified a potential issue with short battery run-times on the affected devices. All lot and serial numbers are affected, as indicated by UDI codes (01) 0 0801902 09219 9 and (01) 3 0801902 09219 0.
Healthcare facilities that operate this device should review their affected inventory and contact ARROW INTERNATIONAL Inc. for specific guidance regarding this recall.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- battery-failure
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 09219 9
- (01) 3 0801902 09219 0
- All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
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