The Recall Desk
SevereFDA (Devices)·Z-0436-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Issue

Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.

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 recall with no reported deaths or injuries. The device is used for cardiac support, and battery runtime issues could impair device performance. FDA Class I classification mandates a minimum severity score of 4.

Plain-English summary

Arrow International Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AC3 IABP NA/AJLA, REF IAP-0601) due to a potential issue with short battery run-times. This is a Class I recall affecting all lot and serial numbers worldwide.

The affected devices are intra-aortic balloon pumps distributed globally. The recall addresses a potential issue with short battery run-times that may impact device function during use.

All lot and serial numbers of the product are affected. Device identifiers included in this recall are UDI/DI (01) 2 0801902 18177 4 and (01) 2 0801902 18177 7.

Healthcare providers and facilities using the AutoCAT2 Intra-Aortic Balloon Pump should monitor official FDA communications and contact Arrow International Inc. for additional information about this recall.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device
Hazard
  • battery-runtime
  • power-loss

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 18177 4
  • (01) 2 0801902 18177 7
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category