Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump 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: The device is classified as FDA Class I, which establishes a minimum severity level of 4. Although no illnesses or deaths have been reported, the issue with battery run-times in a critical cardiac support device presents a significant safety concern.
Plain-English summary
Arrow International is recalling approximately 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (also known as AUTOCAT 2 IABP) worldwide. The devices are affected by a potential issue with short battery run-times.
Intra-aortic balloon pumps are critical cardiac support devices used in medical settings to assist heart function. Short battery run-times could affect the device's ability to provide continuous support during treatment.
The affected units carry UDI codes 0 0801902 05172 1 and 0 0801902 05172 2, and the recall includes all lot and serial numbers of the model REF IAP-0400. The devices have been distributed worldwide.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Category
- Medical Device — Cardiac Device
- Affected units
- 1,394
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 05172 1
- (01) 0 0801902 05172 2
- 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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