The Recall Desk
HighFDA (Devices)·Z-0453-2023·Announced 2022-12-21

Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime

The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.

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: Although the FDA classified this as Class I, the source describes a potential issue with no reported illnesses or injuries. This fits the High (3) definition: a risk-of-harm product where injury has not yet been reported. Per the rubric, theoretical hazards with no reported incidents are capped at High severity.

Plain-English summary

The Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model IAP-0500NL, has been recalled due to a potential issue with short battery run-times.

The FDA classified this as a Class I recall affecting 4 units distributed worldwide by Arrow International Inc. The affected devices are identified by UDI/DI codes (01) 0 0801902 09172 7 and (01) 3 0801902 09172 8, with all lot and serial numbers included.

Intra-aortic balloon pumps provide cardiac support in critical care settings. No reported illnesses or injuries have been associated with this recall issue.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Assist 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 09172 7
  • (01) 3 0801902 09172 8
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category