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Medtronic Vascular Recalls
230 recalls on record · October 9, 2013 to May 18, 2022 · Medical Devices
Recalls by year
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 18, 2022Medical DevicesFDA
Medtronic Vascular, Inc. recalls Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Hazard: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
May 18, 2022Medical DevicesFDA
Medtronic Vascular, Inc. recalls Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:A
Hazard: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
March 2, 2022Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C
Hazard: Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
December 1, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE
Hazard: Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
December 1, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE ST
Hazard: Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
December 1, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Hazard: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
August 4, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C1
Hazard: During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
August 4, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49
Hazard: During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
July 7, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Hazard: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
June 23, 2021Medical DevicesFDA
Medtronic Vascular recalls Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire c
Hazard: The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
March 17, 2021Medical DevicesFDA
Medtronic Vascular recalls Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Hazard: Sterility may be compromised due to an unsealed pouch
March 17, 2021Medical DevicesFDA
Medtronic Vascular recalls Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Hazard: Sterility may be compromised due to an unsealed pouch
March 17, 2021Medical DevicesFDA
Medtronic Vascular recalls Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Hazard: Sterility may be compromised due to an unsealed pouch
March 17, 2021Medical DevicesFDA
Medtronic Vascular recalls Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Hazard: Sterility may be compromised due to an unsealed pouch
March 17, 2021Medical DevicesFDA
Medtronic Vascular, Inc. recalls Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Hazard: Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
October 28, 2020Medical DevicesFDA
Medtronic Vascular recalls Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 0061
Hazard: Subsequent failure of catheters in the field and failed quality testing
October 28, 2020Medical DevicesFDA
Medtronic Vascular recalls Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 0061
Hazard: Subsequent failure of catheters in the field and failed quality testing
October 28, 2020Medical DevicesFDA
Medtronic Vascular recalls Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 00
Hazard: Subsequent failure of catheters in the field and failed quality testing
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
October 9, 2019Medical DevicesFDA
Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular use
Hazard: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.