The Recall Desk
SevereFDA (Devices)·Z-0437-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.

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: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the established rubric. Short battery runtime on a cardiac support device carries serious potential risk to patient care. Although no illnesses or injuries are documented in the source material, the Class I classification itself reflects the FDA's assessment of serious hazard to patients.

Plain-English summary

Arrow International Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AC3 IABP NA/AJLA, model reference IAP-0601, IPN 917288). The recall affects all lot and serial numbers of this device distributed worldwide.

The company has identified a potential issue with short battery run-times on the affected devices. An intra-aortic balloon pump is a cardiac support device that assists heart function during periods of cardiac compromise. Inadequate battery run-time could limit the device's ability to provide continuous support to patients who depend on it.

Healthcare facilities, physicians, and patients using this device should be aware of this issue. If you have this device in your facility or have concerns about its operation, contact Arrow International Inc. immediately. The U.S. Food and Drug Administration (FDA) classified this recall as Class I, its most serious classification, indicating a serious hazard to patient health.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • short-battery-life
  • 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) 2 0801902 17209 3
  • (01) 2 0801902 17209 6
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category