ACCUTRAK DELIVERY CATHETER SYSTEM Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
108
Reports (30d)
2
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Study Observations on Valve-Related Deaths
evolut, patients, study, tavi, included
1
reports
Transient Bradycardia During Pre-Implant BAV
dcs, non medtronic, tav, bioprosthetic, balloon
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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