FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.
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: This is an FDA Class II recall for a manufacturing defect in a critical cardiac device. The undersized dilator may impair proper catheter function. Without reported adverse events in the source, this meets the criteria for High severity as a risk-of-harm product where injury has not been reported.
Plain-English summary
Datascope Corporation is recalling certain lots of the Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter. The recalled units contain an undersized dilator, a manufacturing defect affecting approximately 10,427 units. The Sensation Plus catheter is used to provide mechanical circulatory support in cardiac patients.
The undersized dilator may impair the proper insertion and function of the catheter during clinical use.
The affected units have been distributed to 24 countries internationally and additional units are awaiting domestic distribution in the United States. Specific lot numbers and UDI codes identifying the affected products are available in the FDA recall documentation. Healthcare providers and facilities should immediately discontinue use of the affected lots and contact Datascope Corporation for replacement units or further instructions.
The recalled product
- Product
- Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
- Manufacturer
- Datascope Corporation
- Hazard
- manufacturing-defect
- undersized-dilator
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 (20)
- Code information reads "UDI-DI
- Lot No.
- Finished Goods Part No.": 10607567108605
- 3000168086
- 0684-00-0576-01
- 10607567108605
- 3000217952
- 10607567109633
- 3000166607
- 0684-00-0576-01U
- 3000169722
- 3000172352
- 3000172353
- 3000176574
- 3000176633
- 3000185680
- 3000196023
- 3000199196
- 3000199197
- 3000199198
Distribution
Distribution scope not specified by the agency.
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