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 duri
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling certain lots of its Captivator Polypectomy Snare, a single-use medical device used to cut and remove polyps during endoscopic procedures. The affected device consists of a flexible wire cable and loop that extends and retracts from a flexible outer sheath. The recall affects lots 25143083 and 25508441 with expiration dates between February 2, 2023 and May 14, 2023, which were distributed worldwide.
The company identified a potential defect where the snares may not cut and remove polyps as intended. Possible consequences include prolonged procedure time, tissue damage, and self-limited bleeding. In severe cases, patients could experience immediate or delayed hemorrhage or perforation requiring surgical intervention, though the company states such severe injuries are remote and have not been reported to date. The defect could also result in incomplete removal of the targeted tissue.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: World wide distribution. 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.