The Recall Desk
SevereFDA (Devices)·Z-0448-2023·Announced 2022-12-21

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump recalled for short battery runtime

Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 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 recall is classified as FDA Class I, which per the rubric requires a minimum severity score of 4 (Severe). A battery failure on a critical cardiac support device such as an intra-aortic balloon pump poses a potential for serious adverse health consequences.

Plain-English summary

The Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP, model REF IAP-0500E) has been recalled by manufacturer ARROW INTERNATIONAL Inc. due to a potential issue with short battery run-times on the affected devices.

Affected units are identified by UDI/DI codes (01) 0 0801902 09216 8 and (01) 3 0801902 09216 9, with all lot and serial numbers included in the recall scope. A total of 112 units have been affected and distributed worldwide.

Healthcare facilities and users of affected devices should contact ARROW INTERNATIONAL Inc. or the FDA for guidance on appropriate response actions.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • battery-failure

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 09216 8
  • (01) 3 0801902 09216 9
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category