The Recall Desk
SevereFDA (Devices)·Z-0446-2023·Announced 2022-12-21

Arrow AutoCAT 2 Cardiac Pump Recalled for Battery Runtime Issues

Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.

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 has classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. No injuries or illnesses are reported in the source text, preventing a higher classification.

Plain-English summary

The Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP), model REF IAP-0400J (IPN000308), is being recalled by ARROW INTERNATIONAL Inc. This cardiac pump device is used in intra-aortic balloon support therapy.

The FDA has issued a Class I recall due to a potential issue with short battery run-times on the affected devices.

The recall affects devices with worldwide distribution across all lot and serial numbers.

Healthcare facilities and providers currently using this device should contact ARROW INTERNATIONAL Inc. for further guidance and instructions regarding this recall.

The recalled product

Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Intra-Aortic Balloon Pump
Hazard
  • battery-malfunction
  • 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 04341 2
  • (01) 3 0801902 04341 3
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category