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 procedures. The device consists of a flexible wire cable and loop that extends and retracts from a flexible outer sheath. The company identified a potential defect in specific lots that could prevent the snare from cutting and removing polyps as intended.
If the snare fails to cut properly, procedures may take longer and patients could experience tissue damage, self-limited bleeding, or in rare cases, serious complications including delayed hemorrhage or perforation that might require surgery. To date, no complaints of these severe injuries have been reported. The affected lots have expiration dates ranging from February 5, 2023 through May 13, 2023, and were distributed worldwide. The source document does not specify what remedy affected consumers should pursue.
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 #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.