Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling Captiflex Snares, which are single-use polypectomy devices consisting of a flexible wire cable and loop used to cut and remove polyps. The recall affects specific lot numbers (25321152, 25338467, 25426642) with expiration dates ranging from March 6, 2023 through March 31, 2023, and these devices were distributed worldwide. The company identified a potential inability of the snares to cut and remove polyps as intended.
The potential consequences of the snares not performing properly include prolonged procedure duration, tissue damage, and self-limited bleeding. More severe potential injuries could include immediate or delayed hemorrhage or perforation requiring surgical intervention, though the company notes this risk is remote and no such complaints have been reported to date. The malfunction could also result in inadequate removal of target tissue.
The source document does not specify a remedy or corrective action for consumers who have this product.
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 #: M00562401 Inner Package UPN #: M00562400 GTIN: 08714729019411 Lot #s: 25321152, 25338467, 25426642 Expiration Dates: 6-Mar-23 through 31-Mar-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.