The Recall Desk

FDA (Devices) recall action 86886

Covidien Llc recalled 2 products on 2021-01-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-01-06
Critical
0
Units
—

Why these products were recalled

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

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

1–2 of 2

  • SevereFDA (Devices)··2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Loading Units

    FDA is recalling specific lots of Covidien TA Auto Suture Vascular Loading Units due to a damaged internal component that may prevent adequate hemostasis.

    Product
    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components

    The FDA is recalling specific lots of Covidien TA Auto Suture Vascular Staplers because a damaged internal component may prevent adequate hemostasis or cause tissue damage.

    Product
    Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
    Category
    Distribution
    0 states