Maquet Datascope Intra-Aortic Balloon Pump Recall for Fan Assembly Failure
Maquet Datascope is recalling 11,881 Intra-Aortic Balloon Pump units worldwide due to a potential fan assembly failure that could cause the power supply to overheat and shut down without warning.
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 mechanical failure could cause an unexpected shutdown during a procedure, representing a risk of harm even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling 11,881 units of the Datascope System 98/98xt, CS 100/CS100i, and CS 300 Intra-Aortic Balloon Pumps. These electromechanical systems are used to inflate and deflate intra-aortic balloons during cardiovascular procedures. The recall covers units distributed nationwide in the United States and in approximately 104 other countries.
The recall is being issued because of a potential mechanical failure in the fan assembly associated with the power supply. If the fan assembly fails, the power supply may overheat, which could cause the Intra-Aortic Balloon Pump to shut down without warning.
Healthcare facilities and users should identify affected units by checking the model numbers and serial codes listed in the official recall notice. Users should contact Maquet Datascope for instructions on how to address the defect and ensure patient safety during cardiovascular procedures.
The recalled product
- Product
- Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiovascular
Distribution
Distributed nationwide across the United States.
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