Boston Scientific Corporation: 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 dat

Agency Publication Date: August 5, 2020

Affected Products

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 loo

Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23

Outer Package UPN #: M00561311 Inner Package UPN #: M00561310 GTIN: 08714729019251 Lot #s: 25199777, 25330546, 25374640, 25424470, Expiration Dates: 11-Feb-23 through 31-Mar-23

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

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

Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23

Product: 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 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.

Outer Package UPN #: M00562401 Inner Package UPN #: M00562400 GTIN: 08714729019411 Lot #s: 25321152, 25338467, 25426642 Expiration Dates: 6-Mar-23 through 31-Mar-23

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86004

Status: Active

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23

Outer Package UPN #: M00561311 Inner Package UPN #: M00561310 GTIN: 08714729019251 Lot #s: 25199777, 25330546, 25374640, 25424470, Expiration Dates: 11-Feb-23 through 31-Mar-23

Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23

Outer Package UPN #: M00562401 Inner Package UPN #: M00562400 GTIN: 08714729019411 Lot #s: 25321152, 25338467, 25426642 Expiration Dates: 6-Mar-23 through 31-Mar-23