—#83353

Product

Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.

FDA product code: FHN — Ligator, Hemorrhoidal
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K040148
Affected lot / code info: Product code M00522600, lot 0ML9042402 and Product code M00522602, lot 0ML9042701.

Why it was recalled

The clip may not deploy or, if deployed, the clip may not release from the tissue.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.

Timeline

Recall initiated: 2009-06-17
Posted by FDA: 2009-09-02
Terminated: 2010-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83353. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.