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.
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: 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.
- 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) 1 0801902 18178 4
- (01) 1 0801902 18178 7
- 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
Same manufacturer · ARROW INTERNATIONAL Inc.
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Similar recalls
- SevereArrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure
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- SevereArrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
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