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.
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 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.
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.
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.
See all 31 products in this recall →Related recalls
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Similar recalls
- SevereArrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure
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- SevereDatascope Cardiosave Rescue IABP Recalled for Battery Maintenance Issues
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