The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0456-2023·Announced 2022-12-21

Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices."

Plain-English summary

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP) devices, REF IAP-0500J (IPN000334), are being recalled due to a potential issue with short battery run-times.

The recall affects all lot and serial numbers and applies to devices distributed worldwide. Arrow International Inc., the manufacturer, initiated this recall.

Healthcare providers and patients currently using this device should contact Arrow International Inc. for additional information and guidance. The U.S. Food and Drug Administration (FDA) classified this as a Class I medical device recall.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / Life Support
Hazard
Affected units
1

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 09178 9
  • (01) 3 0801902 09178 0
  • 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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Same manufacturer · ARROW INTERNATIONAL Inc.

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