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 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 involves a risk-of-harm medical device where severe injuries like hemorrhage or perforation are possible but have not yet been reported, fitting the 'High' severity criteria for unreported injury risks.
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 covers lots with expiration dates ranging from January 20, 2023, to May 14, 2023, which 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, or self-limited bleeding. 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 remote, and no such complaints have been reported to date. The failure may also result in the inadequate removal of target tissue.
Healthcare providers and facilities that have received these devices should stop using the affected lots and contact Boston Scientific for instructions on return or replacement. Patients who have had procedures using these devices 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 (9)
- 25164173
- 25185062
- 25187234
- 25226123
- 25255681
- 25336754
- 25403003
- 25508379
- 25524901 Expiration Dates: 20-Jan-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.
See all 7 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- HighBoston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty
FDA (Devices) · 2012-06-27
- ModerateBoston Scientific Pediatric Snare Recalled for Extension Difficulty
FDA (Devices) · 2012-06-27
- LowBoston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals
FDA (Devices) · 2021-03-10
- LowBoston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals
FDA (Devices) · 2021-03-10
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighHobbs Medical Polypectomy Snare May Fail to Close Properly
FDA (Devices) · 2022-07-27