Arrow AutoCAT2 cardiac pump recalled for short battery run-times
Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.
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: The FDA classified this recall as Class I, which per the severity rubric requires a minimum score of 4 (Severe). No deaths or injuries have been reported in the source text.
Plain-English summary
Arrow International Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AUTOCAT2 WAVE, reference IAP-0500) due to a potential issue with short battery run-times on the affected devices. The devices are distributed worldwide.
This recall involves 2,678 units. All lot and serial numbers of the specified model are included in this recall. The FDA classified this recall as Class I.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Category
- Medical Device — Cardiac Device
- Hazard
- Affected units
- 2,678
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 05171 4
- (01) 0 0801902 05171 5
- 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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Same hazard · short battery runtime
See all →- SevereArrow AutoCAT2 Intra-Aortic Balloon Pump Battery Run-Time Issue
FDA (Devices) · 2022-12-21