Intellanav Stablepoint Ablation Catheter
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
Intellanav Stablepoint Ablation Catheter Standard Curve |
More than 10 numbers, contact manufacturer. |
M004ERFSDS96200 |
Intellanav Stablepoint Ablation Catheter Large Curve |
More than 10 numbers, contact manufacturer. |
M004ERFSDS9620K20 |
Issue
During the execution of 2 year real time aging, an issue was identified during bubble testing where there was a leak in the sealed sterile barrier of the packaging. Further investigation determined the manufacturing work instruction was not aligned to the design drawing. It was determined during review of the dv failure that the breach of the sterile barrier was related to the incorrect placement of the IFU during the packaging process.
Recall start date: March 24, 2023
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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