The Recall Desk

FDA (Devices) recall action 66567

Medtronic Vascular recalled 8 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2013-11-27
Critical
1
Units
14,431

Why these products were recalled

Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medt

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

1–8 of 8

  • SevereFDA (Devices)··2013-11-27

    Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic Vascular Recalls Attain Hybrid Guide Wires Due to Coating Defect

    Medtronic Vascular is recalling 1,674 Attain Hybrid Guide Wires because the PTFE coating may delaminate and detach from the device.

    Product
    ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic Zinger Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.

    Product
    Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.

    Product
    COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be…
    Category
    Distribution
    45 states
  • CriticalFDA (Devices)··2013-11-27

    Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2013-11-27

    Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may…
    Category
    Distribution
    45 states