The Recall Desk

FDA (Devices) recall action 65182

Cordis Corporation recalled 5 products on 2013-06-12

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2013-06-12
Critical
0
Units
2,724

Why these products were recalled

Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.

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

1–5 of 5

  • HighFDA (Devices)··2013-06-12

    Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues

    Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-06-12

    Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

    Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

    Product
    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-06-12

    Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

    Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

    Product
    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-06-12

    Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

    Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2013-06-12

    Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

    Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Distribution
    22 states