The Recall Desk

FDA (Devices) recall action 87221

Boston Scientific Corporation recalled 3 products on 2021-03-10

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-03-10
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • LowFDA (Devices)··2021-03-10

    Boston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals

    Boston Scientific is recalling Captivator II Single-Use Polypectomy Snares because users reported incomplete pouch seals before use.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-03-10

    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.

    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; M005
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2021-03-10

    Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals

    Boston Scientific is recalling Captivator and Captiflex polypectomy snares because users reported incomplete pouch seals before patient use.

    Product
    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), M
    Category
    Distribution
    0 states