The Recall Desk
SevereFDA (Devices)·Z-0426-2023·Announced 2022-12-21

Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times

Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump 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: The device is classified as FDA Class I, which establishes a minimum severity level of 4. Although no illnesses or deaths have been reported, the issue with battery run-times in a critical cardiac support device presents a significant safety concern.

Plain-English summary

Arrow International is recalling approximately 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (also known as AUTOCAT 2 IABP) worldwide. The devices are affected by a potential issue with short battery run-times.

Intra-aortic balloon pumps are critical cardiac support devices used in medical settings to assist heart function. Short battery run-times could affect the device's ability to provide continuous support during treatment.

The affected units carry UDI codes 0 0801902 05172 1 and 0 0801902 05172 2, and the recall includes all lot and serial numbers of the model REF IAP-0400. The devices have been distributed worldwide.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Device
Hazard
  • battery-malfunction
  • 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 05172 1
  • (01) 0 0801902 05172 2
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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