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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning."
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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