BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-1168-2021 · Initiated January 19, 2021

    Recall

    Recall Number
    Z-1168-2021
    Event Number
    87221
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FDI
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    January 19, 2021
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    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.

    Reason

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

    Action

    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.

    Distribution

    US nationwide distribution.

    Quantity

    335,788 units total (Domestic: 222,882, Foreign: 112,906)