The Recall Desk
Agency classClass IOur severity: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.

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 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
Affected units
29

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.

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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