The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0435-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.

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: FDA Class I medical device recall; the rubric specifies that Class I recalls never go below severity 4. The affected device is a life-critical intra-aortic balloon pump used in cardiac care, and battery run-time deficiency could result in device malfunction. No illnesses or deaths have been reported in the available source material.

Plain-English summary

Arrow International's AutoCAT2 Intra-Aortic Balloon Pump (AC3 IABP NA/AJLA, Model REF IAP-0601) is the subject of a Class I FDA recall due to a potential issue with battery run-times. The recall covers all lot and serial numbers of the device and affects units distributed worldwide.

An intra-aortic balloon pump is a critical device used in cardiac care to support the heart during treatment. The issue identified in this recall concerns the battery run-time on the affected devices, which may be shorter than the manufacturer's specifications.

The FDA has classified this as a Class I recall, indicating potential for serious adverse health consequences or device failure.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Intra-Aortic Balloon Pump
Hazard

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 09118 5
  • (01) 0 0801902 09118 6
  • 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 →

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