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Medtronic Vascular, Inc. FDA Recalls
10 recalls on file across devices, 1 of them Class I and 9 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:AClass IIMar 23, 2022Packaging for Balloon Catheters may be damaged resulting in |
| Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx OnlyClass IIMar 23, 2022Packaging for Balloon Catheters may be damaged resulting in |
| Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313CClass IIDec 21, 2021Stent Graft Systems built with specific batches of taper tip |
| Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STClass IIOct 15, 2021Due to, during stent graft deployment, the spindle may detac |
| Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBEClass IIOct 15, 2021During stent graft deployment, the spindle may detach from t |
| Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE Class IIOct 15, 2021Due to, during stent graft deployment, the spindle may detac |
| Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C1Class IIJun 7, 2021During product complaint investigation, it was determined th |
| Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49Class IIJun 7, 2021During stent graft deployment, the radiopaque (RO) marker bo |
| Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.Class IIApr 28, 2021Incorrect stentstop assembly (18fr) was used to build the de |
| Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).Class IFeb 12, 2021Due to the presence of type IIIb endoleaks, stent fractures, |