Resolute Integrity™ RSINT25012UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT25012UX MicroTrac 2.50X12RX · Class 3 · Implant
All models of Resolute Integrity (52)
Data updated Oct 18, 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 00643169037359), received between Dec 4, 2017 and Dec 4, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DES TO TREAT A NON- CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL RCA. NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED AND THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. DURING THE PROCEDURE THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY BUT NO EXCESSIVE FORCE USED. A NON MEDTRONIC GUIDE EXTENSION CATHETER WAS USED. IT WAS REPORTED THAT THE STENT WAS BEING ADVANCED PAST THE PROXIMAL RCA WHEN THE STENT DISLODGED. THE PHYSICIAN CONTINUED WITH THE CASE AND PLACED A NON-MDT STENT OVER IT. THE INFLATION DEVICE REMAIN ON NEUTRAL PRESSURE. THE PATIENT LEFT THE CATH LAB IN NORMAL CONDITION AND NO FURTHER INJURIES WERE REPORTED POST PROCEDURE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7078403 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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