Use caution Medical device recall · FDA · Published January 19, 2021

Boston Scientific Captivator/Captiflex Polypectomy Snares: Incomplete Packaging Seal Risk

Boston Scientific recalls Captivator and Captiflex single-use polypectomy snare devices with incomplete pouch seals that could lead to device failure during use. Affected units include specific model numbers and batch dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1168-2021Medical device Boston Scientific ›

Use caution until it’s fixed

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Take action

Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Captivator and Captiflex single-use polypectomy snare devices because the packaging seal may be incomplete. This could cause the device to fail during medical procedures, potentially leading to patient injury. Read more at govinfonow.com/recall/63364-boston-scientific-captivator-captiflex-polypectomy-snares-incomplete-packaging-seal-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63364-boston-scientific-captivator-captiflex-polypectomy-snares-incomplete-packaging-seal-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1168-2021

Cite this page

“Boston Scientific Captivator/Captiflex Polypectomy Snares: Incomplete Packaging Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63364-boston-scientific-captivator-captiflex-polypectomy-snares-incomplete-packaging-seal-risk. Based on FDA recall #Z-1168-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1168-2021%22&limit=1).

The FDA announced on Jan. 19, 2021, that Boston Scientific Corporation is recalling Captivator and Captiflex Single-Use Polypectomy Snares due to packaging with incomplete seals. The agency issued the voluntary Class II recall affecting 335,788 units distributed nationwide.

How to tell if you have it

Captivator Single-Use Polypectomy Snares
Captiflex Single-Use Polypectomy Snares
UPCs: 08714729019251, 08714729019312, 08714729019336, 08714729019350, 08714729019411, 08714729019459, 08714729071068, 08714729501640, 08714729501657, 08714729747680, 08714729747833, 08714729747857, 08714729747871, 08714729747932, 08714729747956
Lot/Batch codes: 24725319, 24782695, 24842597, 24812577, 24889757, 24719202, 24709536, 24773287, 24782693, 24732964, 24889755, 24780939, 24882357, 24782689, 24782687, 24729758, 24961643, 24961645, 24989260, 24844193, 25010054, 25016793

The hazard

According to the FDA, users noted an incomplete pouch seal prior to using the device in a patient. The recall addresses this packaging defect which could compromise the sterility of the single-use polypectomy snares.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the April 10, 2026, Stryker BARD EP XT Decapolar Steerable Catheter Recall and the April 15, 2026, Covidien EndoStitch Polysorb Loading Unit Recall.

How to tell if you have this one

Check for the outer box GTIN: 08714729019251, 08714729019312, 08714729019336, 08714729019350, 08714729019411, or 08714729501640. The inner pouch GTIN is 08714729747680, 08714729747833, 08714729747857, 08714729747871, 08714729747932, 08714729747956, or 08714729747994. Affected units have specific batch numbers listed in the recall.

Brand
Boston Scientific
Product
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US nationwide distribution.

Recall number	Product, codes & lots
Z-1168-2021	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), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.; Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695, Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577, Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287, Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939, Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758, Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643 Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193, Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054, Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.
Z-1169-2021	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.; 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
Z-1170-2021	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; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.; Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455 Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901 Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132 Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345 Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739 Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534 Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136 Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218 Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343 Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438

Based on the official FDA remedy

What to do — step by step

Check Device Packaging
Verify the outer box GTIN and inner pouch GTIN numbers to confirm if your device is affected by this recall.
Contact Manufacturer
Reach out to Boston Scientific directly for further assistance or to confirm if your device is part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 50 days after the firm started it.

Jan 19, 2021Firm started the recall
Mar 4, 2021FDA classified it Class II
Mar 10, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any specific batch numbers that are affected?

Yes, specific batch numbers like 24725319, 24782695, 24842597, and others are listed in the recall notice.

Similar recalls

Latest medical device recalls

Keep exploring

More Boston Scientific recalls

Link to this recall

<a href="https://govinfonow.com/recall/63364-boston-scientific-captivator-captiflex-polypectomy-snares-incomplete-packaging-seal-risk">Boston Scientific Captivator/Captiflex Polypectomy Snares: Incomplete Packaging Seal Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1168-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1168-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.