—#185564

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.

FDA product code: FDI — Snare, Flexible
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133987
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2021-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.