Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals
Boston Scientific is recalling Captivator and Captiflex polypectomy snares because users reported incomplete pouch seals before patient 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 specific hazard is a packaging seal issue with no reported injuries or illnesses, fitting the criteria for Low severity (packaging-only problems).
Plain-English summary
Boston Scientific Corporation is recalling Captivator and Captiflex 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. This packaging defect could potentially compromise the sterility or integrity of the medical device.
Healthcare providers and facilities should stop using the affected lots and contact Boston Scientific for further instructions or replacement. The specific lot numbers and GTINs are listed in the official FDA recall record Z-1168-2021.
The recalled product
- Product
- Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10)…
- 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 (13)
- 24782695
- 24812577
- 24719202
- 24709536
- 24773287
- 24732964
- 24889755
- 24780939
- 24782689
- 24782687
- 24729758
- 24989260
- 24844193
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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