Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a component failure could lead to abrupt cessation of function. The source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AC3 Optimus Intra-Aortic Balloon Pump (Product Code IAP-0700). The recall covers specific serial number ranges distributed worldwide.
The recall is due to a potential issue with a component within the device that is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of motor connector wires. These issues may cause the pump to display "System Error 3" and "High Baseline" alarms on the screen, leading to an abrupt cessation of function or an inability to start the IABP.
Healthcare providers and facilities should check their inventory for the affected serial numbers. The source text does not specify specific consumer actions beyond the recall notice, but the device should be evaluated for the described component issues.
The recalled product
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,123
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 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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