—#123624

Product

Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

FDA product code: FED — Endoscopic Access Overtube, Gastroenterology-Urology
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657

Why it was recalled

The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Root cause (FDA determination)

Component design/selection

Action the firm took

Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account 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 as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.

Timeline

Recall initiated: 2013-11-05
Posted by FDA: 2013-12-04
Terminated: 2014-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.