Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Time
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 requires a minimum severity score of 4 per the rubric. No deaths or reported illnesses appear in the source text, which prevents a Critical rating.
Plain-English summary
Arrow International Inc. is recalling the AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model REF IAP-0500F (IPN000323), due to a potential issue with short battery run-times on the affected devices. A total of 48 units have been distributed worldwide.
The intra-aortic balloon pump is a critical cardiac support device. Short battery run-times could limit the device's operational duration during patient care. The FDA has classified this as a Class I recall.
Healthcare facilities and medical professionals using these devices should immediately contact Arrow International Inc. for further instructions. The recall affects all lot and serial numbers of the specified device model.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Affected units
- 48
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 09218 2
- (01) 3 0801902 09218 3
- 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.
See all 31 products in this recall →Related recalls
Same manufacturer · ARROW INTERNATIONAL Inc.
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