Boston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals
Boston Scientific is recalling Captivator II Single-Use Polypectomy Snares because users reported incomplete pouch seals before use.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging defect (incomplete seal) with no reported injuries or illnesses, fitting the criteria for a low-risk packaging-only problem.
Plain-English summary
Boston Scientific Corporation is recalling Captivator II Single-Use Polypectomy Snares. The recall involves 335,788 units distributed nationwide in the United States and internationally.
The recall was initiated because users noted an incomplete pouch seal prior to using the device in a patient. The affected products are identified by specific outer box and inner pouch GTINs and lot numbers listed in the agency's structured data.
Healthcare providers and facilities should stop using the affected devices and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Endoscopy
- Hazard
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)
- 24670592
- 24679619
- 24676929
- 24952552
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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