—#109521

Product

Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

FDA product code: FDI — Snare, Flexible
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K941750
Affected lot / code info: Lot Number: 14974048

Why it was recalled

Difficulty in extending snare loop from the catheter

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. 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. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland

Timeline

Recall initiated: 2012-05-16
Posted by FDA: 2012-06-21
Terminated: 2013-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.