429 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
FDA Recall
Terminated
·Medtronic Vascular·Product code ITX·November 1, 2006
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·July 3, 2013
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
FDA Enforcement
Class II
·Terminated·Medtronic Cardiovascular Surgery-the Heart Valve Division·August 24, 2016
Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
FDA Recall
Terminated
·Medtronic Cardiovascular Surgery-the Heart Valve Division·Product code NPT·August 3, 2016
Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWF·May 9, 2008
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
Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascular Cardiopulmonary Bypass. Catalog Number: CB68122
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWF·May 9, 2008
Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog number: M470450E
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWF·May 9, 2008
Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·June 8, 2011
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 Recall
Terminated
·Medtronic Vascular·Product code NKQ·May 4, 2021
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019