The Recall Desk

FDA (Devices) recall action 88158

Medtronic Vascular, Inc. recalled 2 products on 2021-08-04

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
2021-08-04
Critical
0
Units
39

Why these products were recalled

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-08-04

    Medtronic Endurant II Stent Graft Marker Detachment During Deployment

    Medtronic recalls Endurant II stent graft systems: the radiopaque marker bond may detach during deployment. The recall affects 18 devices in U.S. and international distribution. No illnesses or injuries reported.

    Product
    Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2021-08-04

    Medtronic Endurant IIs stent graft system marker detachment recall

    Medtronic is recalling 21 Endurant IIs stent graft systems due to radiopaque marker bond detachment during device deployment. The defect could affect surgical visualization and device positioning.

    Product
    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Distribution
    8 states