The Recall Desk
SevereFDA (Devices)·Z-0450-2023·Announced 2022-12-21

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Time

Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.

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 requires a minimum severity score of 4 per the rubric. No deaths or reported illnesses appear in the source text, which prevents a Critical rating.

Plain-English summary

Arrow International Inc. is recalling the AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model REF IAP-0500F (IPN000323), due to a potential issue with short battery run-times on the affected devices. A total of 48 units have been distributed worldwide.

The intra-aortic balloon pump is a critical cardiac support device. Short battery run-times could limit the device's operational duration during patient care. The FDA has classified this as a Class I recall.

Healthcare facilities and medical professionals using these devices should immediately contact Arrow International Inc. for further instructions. The recall affects all lot and serial numbers of the specified device model.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • battery-runtime-issue
  • device-malfunction

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 09218 2
  • (01) 3 0801902 09218 3
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category