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 specific lots of Captivator Polypectomy Snare devices used to cut and remove polyps during medical procedures. The snares in affected lots may not cut properly, which could result in prolonged procedure time, tissue damage, self-limited bleeding, or in remote cases, more serious complications including hemorrhage or perforation that might require surgery. To date, no such serious injuries have been reported. The affected lots were distributed worldwide and can be identified by specific lot numbers (25199777, 25330546, 25374640, 25424470) with expiration dates ranging from February 11, 2023 through March 31, 2023.
The affected devices are marked with outer package UPN #M00561311 and inner package UPN #M00561310. The source document does not specify what actions affected consumers or users should take regarding this recall.
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 #: M00561311 Inner Package UPN #: M00561310 GTIN: 08714729019251 Lot #s: 25199777, 25330546, 25374640, 25424470, Expiration Dates: 11-Feb-23 through 31-Mar-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.