Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures
Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.
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: The recall involves a high-risk medical device with a structural defect (tip seal leak) that could compromise function, but the source text explicitly states no illnesses or injuries have been reported, capping the score at 3 per the rubric.
Plain-English summary
Datascope Corporation is initiating a voluntary product removal of 996 units of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK. The affected product codes are 0684-00-0576-01U, and the distribution was nationwide.
The recall was initiated because internal pressure (leak) testing identified failures related to the tip seal leak in the SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter. The specific lot numbers involved are 300004515, 3000043376, 3000040272, 3000038372, 3000043374, and 3000045513.
This device is a cardiac assist device designed to support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 996
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 (1)
- 300004515
Distribution
Distributed nationwide across the United States.
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