Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals
Boston Scientific is recalling Captivator, Captiflex, and Sensation 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the hazard is a packaging defect (incomplete seal) rather than a direct biological or mechanical failure causing harm. This aligns with the 'Moderate' criteria for low-risk contamination or precautionary recalls where harm has not been reported.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of Captivator, Captiflex, and Sensation Short Throw Single-Use Polypectomy Snares. The recall involves 335,788 units distributed nationwide in the United States and internationally. The specific product codes and lot numbers are listed in the structured product information.
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 of the single-use device. The source text does not report any illnesses or injuries associated with this issue.
Healthcare providers should stop using the affected lots and contact Boston Scientific for further instructions or a replacement. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670…
- 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 (20)
- 24906823
- 24817145
- 24899710
- 24739786
- 25006735
- 24890051
- 24939626
- 25006729
- 24697822
- 24739587
- 24942292
- 24909214
- 24927642
- 24818605
- 24758832
- 24872119
- 24994171
- 25048397
- 2475126
- 24929431
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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