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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Hazard
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.
Part of a larger recall action
This product is one of 31 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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