THUNDER® THNDR190S (UDI 00763000569396)Recalls & reported problems
Medtronic, Inc. · GDWR THNDR190S THUNDER 5PK 190 ST SIL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000569396), received between Dec 3, 2024 and Dec 3, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE RENAL ARTERIES. DURING THE PROCEDURE THE PATIENT SUFFERED FROM AN INFERIOR BRANCH SPASM. IT WAS STATED THAT INTRA-PROCEDURE THERE WAS SPASM IN THE INFERIOR BRANCH FOR WHICH NITROGLYCERIN WAS ADMINISTERED, RESOLVING THE SPASM. THE PATIENT RECOVERED. THE RATIONALE FOR THE RELATIONSHIP TO THE THERAPY, PROCEDURE AND SPYRAL CATHETER WAS THE SPASM WAS RELATED TO THE WIRE IN THE RENAL ARTERY SYSTEM. THERE IS NO REPORTED MALFUNCTION FOR THE SHERPA GUIDE CATHETER OR THUNDER GUIDEWIRE USED DURING THE PROCEDURE.
Patient problems: Obstruction/Occlusion
MAUDE report 20831282 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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