Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
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 of a life-critical cardiac support device. Per FDA classification criteria, Class I recalls mandate a minimum severity score of 4, indicating significant risk of serious harm if the device fails during critical patient use.
Plain-English summary
Arrow International Inc. is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model REF IAP-0500J (IPN000325). These cardiac support devices have been distributed worldwide.
The recall is due to a potential issue with short battery run-times on the affected devices. An intra-aortic balloon pump is a critical medical device used in hospitals to mechanically support heart function during emergency conditions and acute cardiac procedures.
The affected devices are identified by UDI/DI codes (01) 0 0801902 04342 9 and (01) 3 0801902 04342 0. All lot and serial numbers of the model REF IAP-0500J are included in this recall. Healthcare providers and facilities worldwide that have these devices in use or in inventory are affected.
Healthcare providers should contact Arrow International for guidance on device replacement, repair, or discontinuation of use. The device battery should be evaluated for adequate runtime before any patient use to prevent potential failure during critical cardiac procedures.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Hazard
- Affected units
- 127
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 04342 9
- (01) 3 0801902 04342 0
- 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
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