—#182418

Product

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver 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: K131700
Affected lot / code info: Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23

Why it was recalled

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

Root cause (FDA determination)

Device Design

Action the firm took

BSC will sent the customer communication package on July 6, 2020. The communication package includes a Customer Letter and a Reply Verification Tracking Form.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern: World wide distribution.

Timeline

Recall initiated: 2020-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182418. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.