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.
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 medical device with a functional defect that poses a risk of harm (tissue damage, bleeding), but the source explicitly states that severe injuries have not been reported, 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 defect may result in prolonged procedure duration, tissue damage, self-limited bleeding, or inadequate removal of target tissue. While the most severe potential injuries include hemorrhage or perforation requiring surgery, the company states these severe outcomes are remote and have not been reported as complaints to date.
The affected products have a worldwide distribution. Specific lot numbers include 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, and 25402321, with expiration dates ranging from January 28, 2023, to March 24, 2023. Healthcare providers should stop using these devices and contact Boston Scientific for further instructions.
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)
- 25133479
- 25142120
- 25299896
- 25351474
- 25357539
- 25402321 Expiration Dates: 28-Jan-23 through 24-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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