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 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 company identified a potential defect where the snare may be unable to cut and remove polyps as intended, which could result in prolonged procedure time, tissue damage, self-limited bleeding, or in rare cases, immediate or delayed hemorrhage and perforation that might require surgery. To date, no complaints of these severe injuries have been reported, though the defect creates a risk for inadequate removal of target tissue.
The recall affects seven specific lot numbers (25158564, 25245733, 25245735, 25330549, 25403001, 25439073, and 25513671) with expiration dates ranging from February 4, 2023 through May 14, 2023, distributed worldwide. The product can be identified by the outer package UPN #M00562321 and inner package UPN #M00562320. The source document does not specify a remedy or corrective action for 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 #: M00562321 Inner Package UPN #: M00562320 GTIN: 08714729019336 Lot #s: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, 25513671 Expiration Dates: 4-Feb-23 through 14-May-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.