Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure
Boston Scientific is recalling 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 involves a risk-of-harm medical device where potential injuries like tissue damage or bleeding are described, but the source explicitly states that severe injuries have not been reported and the likelihood is remote, fitting the 'High' criteria for risk-of-harm products without reported injury.
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 is due to a potential inability of the snare to cut and remove polyps as intended.
The affected lots are 25170944, 25219286, 25368742, 25412118, and 25508371, with expiration dates ranging from February 5, 2023, to May 13, 2023. The devices were distributed worldwide. If the snare fails to cut, it could lead to prolonged procedure duration, tissue damage, self-limited bleeding, or inadequate removal of target tissue. While severe injuries such as hemorrhage or perforation requiring surgery are theoretically possible, the likelihood is remote and no such complaints have been reported to date.
Healthcare providers 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 contact 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)
- 25219286
- 25368742
- 25412118
- 25508371 Expiration Dates: 5-Feb-23 through 13-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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