Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect
Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Datascope Corp - Cardiac Assist Division is recalling specific CARDIOSAVE and CS300 Intra-Aortic Balloon Pump units, as well as non-sterile SENSATION and SENSATION PLUS IABC demonstration units. The recall involves 838 units in the United States and 364 units outside the United States, with worldwide distribution.
The recall is due to a manufacturing defect where the ferrule cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If the fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, the cap will prevent the connection of the unit. Additionally, the cap may become dislodged and remain in the IABP's fiber-optic receptacle.
The affected products are identified by specific part numbers including 0998-00-0800-xx, 0998-00-3023-xx, 0998-UC-0800-xx, and 0998-UC-3023-xx, as well as various demonstration unit codes. Users should check their inventory for these specific part numbers and stop using the affected units.
The recalled product
- Product
- CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system…
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Category
- Medical Device — Cardiac Assist
Distribution
Distribution scope not specified by the agency.
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