Skip to content

CAPTIVATOR recallZ-2760-2020 · Boston Scientific Corporation · initiated Jul 6, 2020

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

BSC will sent the customer communication package on July 6, 2020. The communication package includes a Customer Letter and a Reply Verification Tracking Form.

Recall details

Recall number
Z-2760-2020
Status
Open, Classified
Initiated by the company
Jul 6, 2020
Recalling firm
Boston Scientific Corporation
Product code
FDI
FDA submissions
K131700
Distribution
World wide distribution.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 86004).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page