The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class I medical device recall affecting a critical life-support device. However, the source text does not report any illnesses, injuries, or documented harm. The identified hazard—potential short battery run-times—is described as a potential issue without documented patient injury. Per the severity rubric, recalls with no reported illnesses and theoretical hazards score at most 3 (High).

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 →

Related recalls

Same manufacturer · ARROW INTERNATIONAL Inc.

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Same hazard · battery failure

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