ACCUTRAK DELIVERY CATHETER SYSTEM Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
106
Reports (30d)
0
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
6
reports
Infold During TAV Deployment Attempt
deployment, dcs, non medtronic, tav, attempt
1
reports
Valve Dislodgement During Deployment
deployment, dcs, catheter dcs, recaptured, delivery catheter
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.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,454 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,488 reports
Evolut FX
MEDTRONIC, INC. · 12,916 reports
Evolut PRO
MEDTRONIC, INC. · 7,655 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,128 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,405 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data