The Recall Desk
SevereFDA (Devices)·Z-0428-2023·Announced 2022-12-21

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

Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.

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: This is an FDA Class I recall, which mandates a minimum severity of Severe. The affected product is a critical cardiac medical device where short battery run-times present a potential device failure hazard. No illnesses or injuries have been reported.

Plain-English summary

The Arrow AutoCAT2 intra-aortic balloon pump (AEROAUTOCAT2, REF IAP-0435, IPN000312) manufactured by Arrow International Inc. is being recalled worldwide.

The recall addresses a potential issue with short battery run-times on the affected intra-aortic balloon pump devices. These are cardiac medical devices used in clinical settings.

The recall affects 12 units with UDI/DI codes (01) 0 0801902 05174 5 and (01) 0 0801902 05174 6, and applies to all lot and serial numbers. The devices have been distributed worldwide.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / Intra-aortic Balloon Pump
Hazard
  • short-battery-life
  • device-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 05174 5
  • (01) 0 0801902 05174 6
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category