Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
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 severity rubric establishes that FDA Class I recalls never score below Severe (4) due to the inherent critical safety nature of such devices.
Plain-English summary
Arrow International is recalling the Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model REF IAP-05001 (IPN000333), due to a potential issue with short battery run-times. The device is used to provide mechanical cardiac support to hospitalized patients.
The recall affects all lot and serial numbers of the device worldwide.
Healthcare facilities and providers with affected devices should contact Arrow International for corrective actions and instructions. Patients using the device should consult their healthcare provider regarding the device and any potential next steps.
The recalled product
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Category
- Medical Device — Cardiac Pump
- Affected units
- 1
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 09177 2
- (01) 3 0801902 09177 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.
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