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 causing tissue damage or bleeding.
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, and the source explicitly states that severe injuries have not been reported, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Captivator Polypectomy Snares. These single-use medical devices are used to cut and cauterize tissue during endoscopic procedures. The recall affects lots 25199777, 25330546, 25374640, and 25424470, with expiration dates ranging from February 11, 2023, to March 31, 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, self-limited bleeding, or inadequate removal of target tissue. The most severe potential injuries include immediate or delayed hemorrhage or perforation requiring intervention, up to and including open surgery. However, the likelihood of these severe injuries is considered remote, and no such complaints have been reported to date.
Healthcare providers and facilities should stop using the affected lots and contact Boston Scientific for instructions on how to return or dispose of the devices. Patients who have had procedures using these specific lots should consult their healthcare provider if they experience unusual symptoms.
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 (4)
- 25330546
- 25374640
- 25424470
- Expiration Dates: 11-Feb-23 through 31-Mar-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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