The Recall Desk

FDA (Devices) recall action 76841

Abbott Vascular recalled 3 products on 2017-05-24

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
2017-05-24
Critical
1
Units
—

Why these products were recalled

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

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

1–3 of 3

  • CriticalFDA (Devices)··2017-05-24

    Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues

    Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-05-24

    Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-05-24

    Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 10
    Category
    Distribution
    0 states