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 issue that may cause the device to stop working.
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 high-risk medical device where a component failure could lead to abrupt cessation of function. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Arrow International Inc. is recalling 2,123 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump (Product Code IAP-0500NL) distributed worldwide. The recall involves specific serial number ranges: 160714W through 160715W and 160918W.
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. These conditions 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 IABP.
The source text does not specify specific instructions for consumers or healthcare providers regarding immediate actions to take, such as stopping use or contacting a representative, beyond the identification of the affected serial numbers.
The recalled product
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,123
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number Ranges: 160714W through 160715W 160918W
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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