Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk
Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 medical device with a potential mechanical failure that could impact patient safety, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling 29 units of the Cardiosave Intra-Aortic Balloon Pump. This electromechanical system is used to inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle via counterpulsation.
The recall is due to a possibility that the coiled cord assembly, which connects the Cardiosave IABP housing to the dual display head, may fail as a result of mishandling. The affected units were distributed worldwide, including in the United States (specifically Idaho and Florida) and internationally to the United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, and Thailand.
Users of these devices should contact Maquet Cardiovascular, LLC for further instructions on how to proceed with the recall and replacement or repair of the affected units.
The recalled product
- Product
- CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 29
Distribution
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