The Recall Desk

FDA (Devices) recall action 77976

Medtronic Vascular Galway DBA Medtronic Ireland recalled 2 products on 2017-09-27

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
2017-09-27
Critical
0
Units
174,714

Why these products were recalled

Stylette removal difficulties on the Euphora and Solarice products.

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

  • ModerateFDA (Devices)··2017-09-27

    Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.

    Product
    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-09-27

    Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Distribution
    1 state