The Recall Desk
SevereFDA (Devices)·Z-0455-2023·Announced 2022-12-21

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

Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.

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: FDA Class I medical device recall. The severity rubric establishes that FDA Class I recalls never score below Severe (4) due to the inherent critical safety nature of such devices.

Plain-English summary

Arrow International is recalling the Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump (IABP), model REF IAP-05001 (IPN000333), due to a potential issue with short battery run-times. The device is used to provide mechanical cardiac support to hospitalized patients.

The recall affects all lot and serial numbers of the device worldwide.

Healthcare facilities and providers with affected devices should contact Arrow International for corrective actions and instructions. Patients using the device should consult their healthcare provider regarding the device and any potential next steps.

The recalled product

Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Pump
Hazard
  • battery-failure
  • 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 09177 2
  • (01) 3 0801902 09177 3
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category