Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where potential injuries (hemorrhage, perforation) are described but explicitly stated as not yet reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Captivator Polypectomy Snares. These single-use medical devices are used during endoscopic procedures to cut and cauterize tissue. The recall covers lots 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, and 25513671, with expiration dates ranging from February 4, 2023, to May 14, 2023. The products were distributed worldwide.
The recall was initiated because the snares may be unable to cut and remove polyps as intended. If the device fails to perform, it could lead to prolonged procedure duration, tissue damage, or self-limited bleeding. In rare cases, the failure could result in hemorrhage or perforation requiring surgical intervention, though no such injuries have been reported to date. The defect may also result in the inadequate removal of target tissue.
Healthcare providers and facilities should stop using the affected lots immediately. Boston Scientific is managing the recall to ensure these devices are removed from use.
The recalled product
- 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
- Manufacturer
- Boston Scientific Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 25245733
- 25245735
- 25330549
- 25403001
- 25439073
- 25513671 Expiration Dates: 4-Feb-23 through 14-May-23
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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