—#206263

Product

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

FDA product code: DRA — Catheter, Steerable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K223824
Affected 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

Why it was recalled

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).

Root cause (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan

Timeline

Recall initiated: 2024-02-12
Posted by FDA: 2024-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.