The Recall Desk
SevereFDA (Devices)·Z-0429-2023·Announced 2022-12-21

Arrow AutoCAT2 cardiac pump recalled for short battery run-times

Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.

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 per the severity rubric requires a minimum score of 4 (Severe). No deaths or injuries have been reported in the source text.

Plain-English summary

Arrow International Inc. is recalling the Arrow AutoCAT2 Intra-Aortic Balloon Pump (AUTOCAT2 WAVE, reference IAP-0500) due to a potential issue with short battery run-times on the affected devices. The devices are distributed worldwide.

This recall involves 2,678 units. All lot and serial numbers of the specified model are included in this recall. The FDA classified this recall as Class I.

The recalled product

Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Device
Hazard
  • short-battery-runtime

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 05171 4
  • (01) 0 0801902 05171 5
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

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