Medtronic Vascular
FDA adverse event reports naming Medtronic Vascular as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC VASCULAR.
- Total reports
- 1,176
- Deaths
- 132
- Injuries
- 793
- Malfunctions
- 233
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Endovascular Graft, Aortic Aneurysm TreatmentMIH859
- Catheter, PercutaneousDQY57
- Stents, Drains And Dilators For The Biliary DuctsFGE55
- Coronary Drug-Eluting StentNIQ46
- Introducer, CatheterDYB40
- Pump, Infusion, Implanted, ProgrammableLKK19
- Wire, Guide, CatheterDQX16
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionNFA10
- Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX9
- Clamp, VascularDXC8
Recent recalls
- 2021-06-16TerminatedComponent design/selection
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.
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.
- 2020-10-16TerminatedDevice Design
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Subsequent failure of catheters in the field and failed quality testing
- 2020-10-16TerminatedDevice Design
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Subsequent failure of catheters in the field and failed quality testing
- 2020-10-16TerminatedDevice Design
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Subsequent failure of catheters in the field and failed quality testing
- 2020-05-27TerminatedProcess control
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- 2019-10-01TerminatedComponent design/selection
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-01TerminatedComponent design/selection
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-01TerminatedComponent design/selection
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-01TerminatedComponent design/selection
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-01TerminatedComponent design/selection
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
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