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, a single-use medical device used to cut and remove polyps. The device consists of a flexible wire cable and loop that extends and retracts from an outer sheath. For the affected lots, there is a potential inability to cut and remove polyps as intended. This could result in prolonged procedure duration, tissue damage, self-limited bleeding, or in severe cases, immediate or delayed hemorrhage and perforation that may require surgery; however, such severe injuries are considered remote and have not been reported to date.
The recalled lots have outer package UPN #M00562402, inner package UPN #M00562400, GTIN 08714729501640, and lot numbers 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, and 25402321, with expiration dates ranging from January 28, 2023 through March 24, 2023. The devices were distributed worldwide. The source document does not specify what action affected consumers should take.
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 #: M00562402 Inner Package UPN #: M00562400 GTIN: 08714729501640 Lot #s: 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, 25402321 Expiration Dates: 28-Jan-23 through 24-Mar- 23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.