205 results
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16ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·June 3, 2020
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 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. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 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. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
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 be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·November 27, 2013
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.
FDA Enforcement
Class I
·Terminated·Medtronic Vascular·June 23, 2021
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2, .070", REF SA6MB2. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019