—#144674

Product

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

FDA product code: JCT — Prosthesis, Tracheal, Expandable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K141584
Affected lot / code info: Lot Number: 18876596 Exp Date: February 1, 201 8

Why it was recalled

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Nationwide Distribution to AL, CA, MA, and TX.

Timeline

Recall initiated: 2016-03-18
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.