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 consisting of a flexible wire cable and loop used to cut and remove polyps during procedures. The company identified a potential defect in specific production lots that may prevent the snare from cutting and removing polyps as intended. While the most serious potential consequences include hemorrhage or perforation requiring surgery, the company notes these severe injuries are remote and have not been reported to date. Other potential issues include prolonged procedure duration, tissue damage, self-limited bleeding, and inadequate removal of the target tissue.
The recalled device was distributed worldwide and includes ten specific lot numbers (25077093, 25164173, 25185062, 25187234, 25226123, 25255681, 25336754, 25403003, 25379, and 25524901) with expiration dates ranging from January 20, 2023 through May 14, 2023. The affected products can be identified by outer package UPN #M00562341, inner package UPN #M00562340, and GTIN 08714729019350. The source document does not specify what action affected consumers or healthcare facilities 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 #: M00562341 Inner Package UPN #: M00562340 GTIN: 08714729019350 Lot #s: 25077093, 25164173, 25185062, 25187234, 25226123, 25255681, 25336754, 25403003, 25508379, 25524901 Expiration Dates: 20-Jan-23 through 14-May-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.