Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure
Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.
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 is classified as FDA Class I, which mandates a minimum severity score of 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to potential device failure.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500J) distributed worldwide. The recall is due to a potential issue with a component within the device that is susceptible to vibration failure.
This vibration failure can result in fretting, charring, and discoloration of the motor connector wires. These physical changes may cause the device to display "System Error 3" and "High Baseline" alarms on the screen. In some cases, the device may experience an abrupt cessation of function or be unable to start.
The affected serial number ranges are listed in the official recall notice. Users of these devices should contact Arrow International Inc for further instructions on how to proceed.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- 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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