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.
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: 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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