The Recall Desk
SevereFDA (Devices)·Z-0442-2023·Announced 2022-12-21

Arrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue

Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.

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. Per the rubric, FDA Class I recalls score no lower than 4 (Severe). No reported deaths, serious injuries, or hospitalizations were mentioned in the source material.

Plain-English summary

Arrow International Inc. is recalling the Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP), model AC3 Optimus IABP NA/AJLA (reference IAP-0701, IPN916549), distributed worldwide.

There is a potential issue with short battery run-times on these devices. The FDA issued a Class I recall classification for this device.

Healthcare facilities and medical staff using these devices should refer to communications from the manufacturer regarding this recall.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac / Life Support
Hazard
  • battery-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) 1 0801902 18178 4
  • (01) 1 0801902 18178 7
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category