Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International Inc is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.
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 medical device with a risk of abrupt cessation of function, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AC3 Optimus Intra-Aortic Balloon Pump (Product Code IAP-0701). The recall covers devices with 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 device to display "System Error 3" and "High Baseline" alarms, potentially leading to an abrupt cessation of function or an inability to start the IABP.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
- 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.
See all 10 products in this recall →Related recalls
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