Class 1 Device Recall Boston Scientific POLARSHEATH

• Date Initiated by Firm: February 12, 2024
• Date Posted: March 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1302-2024
• Recall Event ID: 94082
• 510(K)Number: K223824
• Product Classification: Catheter, steerable - Product Code DRA
• Product: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
• Code Information: 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
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: Rebecca KinKead-Rubio; 763-494-1133
• Manufacturer 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).
• FDA Determined Cause: Process control
• Action: 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."
• Quantity in Commerce: 461 devices
• Distribution: Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRA and Original Applicant = Boston Scientific Corporation