Boston Scientific Recalls Captiflex Snares Due to Potential Cutting Failure
Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut 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 involves a risk-of-harm product (medical device) where severe injury is a potential consequence, but no injuries have been reported to date, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Captiflex Snares, Single-Use Polypectomy Snares. The recall affects units with lot numbers 25321152, 25338467, and 25426642, which have expiration dates ranging from March 6, 2023, to March 31, 2023. These 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 and/or perforation requiring intervention, up to and including open surgery. However, the likelihood of these severe injuries is remote, and no such complaints have been reported to date.
Healthcare providers and patients should stop using the affected lots of Captiflex Snares. Boston Scientific is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal…
- 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 (2)
- 25338467
- 25426642 Expiration Dates: 6-Mar-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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