—#92063

Product

FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K965147
Affected lot / code info: 13127492, 13188449, 13198517, 13215725, 13241693, 13268177, 13290840, 13302012, 13312896

Why it was recalled

Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.

Root cause (FDA determination)

Packaging

Action the firm took

Boston Scientific sent an "Urgent Medical Device Recall - Immediate Action Required" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific.

Recalling firm

Firm: Boston Scientific Corporation
Address: 500 Commander Shea Blvd, Quincy, Massachusetts 02171-1518

Distribution

Distribution pattern: Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

Timeline

Recall initiated: 2010-04-27
Posted by FDA: 2010-08-25
Terminated: 2011-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.