The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0454-2023·Announced 2022-12-21

Intra-Aortic Balloon Pump Battery Run-Time Issue Recall

Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.

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 FDA has classified this as a Class I recall. Class I recalls require a minimum severity score of 4 per the rubric. Although no illnesses or injuries are reported in the source text, battery failure on an intra-aortic balloon pump—a critical cardiac support device—represents a serious potential harm.

Plain-English summary

Arrow AutoCAT2WAVE intra-aortic balloon pumps have been recalled due to a potential issue with short battery run-times. These cardiac support devices are designed to provide mechanical support to the heart.

Fifteen units manufactured by Arrow International Inc. are subject to this recall, distributed worldwide. All lot and serial numbers of the model REF IAP-0500SV (IPN000327) are included in the recall.

The source indicates a potential issue with battery run-time performance on the affected devices. This represents a potential functional deficiency in a critical life-support device.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support
Hazard
Affected units
15

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 09173 4
  • (01) 3 0801902 09173 5
  • 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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