The Recall Desk
SevereFDA (Devices)·Z-0451-2023·Announced 2022-12-21

FDA Recalls Arrow AutoCAT2WAVE IABP for Short Battery Runtime

The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.

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: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. The potential for short battery run-times on an intra-aortic balloon pump, a life-critical cardiac support device, creates significant risk to patients dependent on mechanical circulatory support.

Plain-English summary

The Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), manufactured by ARROW INTERNATIONAL Inc., is subject to a worldwide recall. This device is used in critical care to support heart function in patients requiring mechanical circulatory support.

The FDA has identified a potential issue with short battery run-times on the affected devices. All lot and serial numbers are affected, as indicated by UDI codes (01) 0 0801902 09219 9 and (01) 3 0801902 09219 0.

Healthcare facilities that operate this device should review their affected inventory and contact ARROW INTERNATIONAL Inc. for specific guidance regarding this recall.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / Intra-aortic Balloon Pump
Hazard

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 09219 9
  • (01) 3 0801902 09219 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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