Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Vibration Failure
Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause the device to stop working or fail to start.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a critical medical device (Intra-Aortic Balloon Pump) where a failure could lead to abrupt cessation of function, which constitutes a significant risk of harm to patients.
Plain-English summary
Arrow International Inc. is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500E). 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 the motor connector wires.
The component issue may cause the pump to display "System Error 3" and "High Baseline" alarms on the screen. It may also result in the abrupt cessation of function or an inability to start the IABP. The affected devices were distributed worldwide.
The source text does not specify specific instructions for consumers or healthcare providers regarding the immediate handling of these devices. Users should refer to the official FDA recall notice for specific guidance on how to proceed.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
- 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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