Intellanav Stablepoint Ablation Catheter
Brand(s)
Last updated
Summary
Product
Intellanav Stablepoint Ablation Catheter
Issue
Medical devices - Sterility Issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73464
Get notified
Receive notifications for new and updated recalls and alerts by category.