The Recall Desk
SevereFDA (Devices)·Z-0444-2023·Announced 2022-12-21

Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

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 classification for a medical device mandates a minimum severity score of 4 per the rubric. No reported deaths, injuries, or hospitalizations are documented in the source material. The device's critical function in cardiac support, combined with the Class I status, justifies the Severe rating.

Plain-English summary

Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP), model IAP-0400E, due to a potential issue with short battery run-times. The device is an intra-aortic balloon pump used to support cardiac function.

The recall affects 29 units with all lot and serial numbers of the device. Worldwide distribution has been confirmed.

This is a Class I FDA recall, the most serious classification level for medical devices. The potential for short battery run-times could affect the device's ability to function as intended during critical cardiac support.

The recalled product

Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support
Hazard
  • battery-runtime
  • device-failure

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) 3 0801902 09203 9
  • (01) 0 0801902 09203 8
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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