Undersized Dilator in Balloon Catheter Insertion Kit Recalled
Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.
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 a risk-of-harm medical device (intra-aortic balloon catheter insertion kit) with a functional defect (undersized dilator) where no injuries or adverse events have been reported, meeting the rubric criterion for Score 3.
Plain-English summary
Datascope Corporation is recalling certain lots of the Insertion Kit for use with SENSATION PLUS 8F, 50cc Intra-Aortic Balloon Catheter. The affected kits contain an undersized dilator that could impair proper insertion of the catheter.
The recall affects 10,427 units distributed to medical facilities in the United States and internationally, including Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and the United Kingdom.
Facilities that have received affected kits should stop using them and contact Datascope Corporation for guidance and replacement units. This is an FDA Class II recall. No adverse events have been reported.
The recalled product
- Product
- Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
- Manufacturer
- Datascope Corporation
- Hazard
- undersized-dilator
- insertion-failure
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 (8)
- Code information reads "UDI-DI
- Lot No.
- Finished Goods Part No.": 10607567108599
- 3000170709
- 0884-00-0019-23
- 10607567108599
- 3000182611
- 3000202083
Distribution
Distribution scope not specified by the agency.
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