CAPTIVATOR II recallZ-1169-2021 · Boston Scientific Corporation · initiated Jan 19, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
FDA root cause category: Process change control
What the company is doing
On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile.
Recall details
- Recall number
- Z-1169-2021
- Status
- Open, Classified
- Initiated by the company
- Jan 19, 2021
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
- Product code
- FDI
- FDA submissions
- K133987
- Distribution
- US nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- CAPTIVATOR II M00561220Boston Scientific Corporation · SNARE, NON-ELECTRICAL1 recall150 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR II M00561190Boston Scientific Corporation · SNARE, FLEXIBLE1 recall22 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87221).
- Z-1168-2021 · Open, ClassifiedCaptivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562…
- Z-1170-2021 · Open, ClassifiedCaptivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M005…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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