Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The source text explicitly states that severe injuries have not been reported and the likelihood is remote, but the potential for harm (hemorrhage/perforation) places it in the High category rather than Moderate.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Captivator Polypectomy Snares. These single-use medical devices consist of a flexible wire cable and loop used to cut and cauterize tissue during endoscopic procedures. The recall affects lots 25143083 and 25508441, with expiration dates ranging from February 2, 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 result in prolonged procedure duration, tissue damage, or self-limited bleeding. In rare cases, the failure could lead to hemorrhage or perforation requiring surgical intervention, although 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 the recalling firm and is responsible for managing the recall process. Users should verify their inventory against the specific lot numbers and expiration dates listed in the recall notice.
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 (1)
- 25508441 Expiration Dates: 2-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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