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U.S. Department of Health and Human Services

Class 2 Device Recall Captivator Polypectomy Snare 27mm, Crescent Loop

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  Class 2 Device Recall Captivator Polypectomy Snare 27mm, Crescent Loop see related information
Date Initiated by Firm July 06, 2020
Create Date August 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-2763-2020
Recall Event ID 86004
510(K)Number K131700  
Product Classification Snare, flexible - Product Code FDI
Product 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.
Code Information Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
508-683-4000
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action BSC will sent the customer communication package on July 6, 2020. The communication package includes a Customer Letter and a Reply Verification Tracking Form.
Distribution World wide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FDI and Original Applicant = BOSTON SCIENTIFIC CORP.
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