The Recall Desk

FDA (Devices) recall action 83797

Medtronic Vascular Galway DBA Medtronic Ireland recalled 2 products on 2019-10-23

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
2019-10-23
Critical
0
Units
151,812

Why these products were recalled

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

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.

1–2 of 2

  • ModerateFDA (Devices)··2019-10-23

    Medtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette may cause removal difficulties.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-10-23

    Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes removal difficulties.

    Product
    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X…
    Category
    Distribution
    0 states