Z-2763-2020Class II

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which...

Name: Z-2763-2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which...
Creator: Boston Scientific Corporation
Published: 2020-07-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-07-06 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of 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... on 2020-07-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2763-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-06
Posted: 2020-08-05
Recalling firm: Boston Scientific Corporation
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.
Product code: FDI Snare, Flexible
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2763-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2759-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2760-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2761-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2762-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2763-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2764-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2765-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05

Product code FDI

K131700Class IISensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy SnaresBoston Scientific Corp / cleared 2013-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)