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FDAFDA · Food and drugs·Recall number Z-2765-2020

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 during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

Published August 12, 2020 · Recall initiated: July 6, 2020

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Boston Scientific Corporation
Distributor
World wide distribution.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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