Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International Inc. is recalling 2,123 AutoCAT2 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 where a component failure could lead to the abrupt cessation of function or inability to start the device. This represents a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc. is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE (Product Code IAP-0500). The devices were distributed worldwide.
The recall is due to a potential issue with a component within the pump that is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of the motor connector wires. These issues may cause the device to display "System Error 3" and "High Baseline" alarms on the screen, or lead to an abrupt cessation of function or an inability to start the IABP.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this defect. Affected serial number ranges are listed in the official recall notice.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
- 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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