Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
This recall is currently active, issued March 26, 2024. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- February 12, 2024
- Posted
- March 26, 2024
- Recall Number
- Z-1302-2024
- Quantity
- 461 devices
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
Distribution
Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
Lot / Code Info
GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976
Root Cause
Process control
Action Taken
Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall to its consignees on 02/12/2024 via hand delivery by sales representative. The notice explained the issue, potential risk, and requested the following actions be taken: Immediately cease distribution of the product and "1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific. 2- Please complete the attached Verification Form even if you do not have any product to return. 3- When completed, please return the Verification Form to your local Boston Scientific office for the attention of Customer_Service_Fax_Number, on or before 20 February 2024. 4- If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return. 5- Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate). If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative."