The Recall Desk
SevereFDA (Devices)·Z-0439-2023·Announced 2022-12-21

Arrow AC3 Optimus cardiac pump recalled due to battery issues

Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers 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 medical device recall. The device is a life-support system used in cardiac procedures. Per FDA standards, Class I recalls indicate devices where malfunction could result in serious health consequences.

Plain-English summary

The Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) is a medical device used in cardiac support procedures to assist heart function.

ARROW INTERNATIONAL Inc. is conducting a worldwide recall of the Arrow AC3 Optimus IABP due to a potential issue with short battery run-times. All lot and serial numbers are included in the recall.

Healthcare facilities and providers with affected devices should contact ARROW INTERNATIONAL Inc. for additional information and guidance regarding this issue.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • short-battery-life
  • 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) 2 0801902 17206 2
  • (01) 2 0801902 17206 5
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category