The Recall Desk
SevereFDA (Devices)·Z-0443-2023·Announced 2022-12-21

Arrow AC3 Optimus Intra-Aortic Balloon Pump Battery Failure Recall

Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.

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 classification mandates a minimum severity of Severe per the rubric. The intra-aortic balloon pump is a critical cardiac life-support device, and battery failure could compromise patient care. No illnesses or injuries have been reported.

Plain-English summary

Arrow International Inc. has recalled the AC3 Optimus Intra-Aortic Balloon Pump (IABP), model REF IAP-0701 (IPN917286), worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

The intra-aortic balloon pump is a critical cardiac support device used in patients with compromised heart function. Short battery run-times could impair the device's ability to provide continuous hemodynamic support during treatment.

Healthcare facilities and clinicians using affected devices should contact Arrow International Inc. for guidance on inspection, replacement, or remediation. The FDA has classified this as a Class I recall.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • battery-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) 2 0801902 17207 9
  • (01) 2 0801902 17207 2
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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