THUNDER® THNDR190JRecalls & reported problems
Medtronic, Inc. · GDWR THNDR190J THUNDER 5PK 190 J SIL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169452275), received between Oct 7, 2022 and Oct 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE THUNDER GUIDEWIRE TO TREAT A LESION IN THE CORONARY SINUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES/KINKS NOTED. NO DIFFICULTIES WERE NOTED WHEN LOADING THE GUIDEWIRE. THE GUIDEWIRE WAS NOT USED WITH OTHER DEVICES PRIOR TO DIFFICULTIES OCCURRING. THE WIRE DID NOT PASS THROUGH THE CELL OF A STENT OR A TIGHT CALCIFIED LESION DURING DELIVERY BUT IT IS BELIEVED THAT THERE WAS PROBABLY A VALVE IN THE CORONARY SINUS. IT WAS REPORTED THAT THE GUIDEWIRE KINKED WHILE IN THE PATIENT. IT WAS STATED THAT THE DISTAL PART OF THE ANGIOPLASTY GUIDEWIRE WAS STUCK IN THE DISTAL PART OF THE CATHETER AND IT COULD NOT BE SEPARATED. WHEN THE WHOLE SYSTEM WAS REMOVED IT WAS OBSERVED THAT THE GUIDEWIRE WAS KINKED AND THE RIGIDITY WAS LOST. IT WAS LATER REPORTED THAT A SECTION OF THE CORE WIRE OF THE THUNDER GUIDE WIRE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15559825 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page