Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Failure
Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 severity score of at least 4 according to the rubric. The hazard involves the potential abrupt cessation of a critical medical device, posing a significant risk to patient safety.
Plain-English summary
Arrow International Inc is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE (Product Code IAP-0535). The recall covers devices distributed worldwide with specific serial numbers listed in the agency's records.
The recall is being issued because a component within the device is susceptible to vibration failure. This failure can result in fretting, charring, and discoloration of the motor connector wires. These issues may cause the pump to display "System Error 3" and "High Baseline" alarms on the screen, potentially leading to an abrupt cessation of function or an inability to start the device.
Healthcare providers and facilities should identify affected units by checking the serial numbers against the provided range. Users should stop using the affected devices and contact Arrow International Inc for instructions on replacement or repair.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
- 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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