Resolute Integrity™ RSINT27518UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT27518UX MicroTrac 2.75X18RX · Class 3 · Implant
All models of Resolute Integrity (52)
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 00643169037564), received between Dec 20, 2016 and Dec 20, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2016Material Deformation; Material Deformation
AN ATTEMPT WAS BEING MADE TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A HEAVILY CALCIFIED LAD LESION. THE DEVICE WAS INSPECTED BEFORE USE AND NO ISSUES WERE REPORTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT NOTED WHILE GETTING TO THE LESION AND EXCESSIVE FORCE WAS NOT USED. WHEN ADVANCEMENT BECAME A LITTLE HARDER THE DEVICE WAS RETRACTED. STENT DEFORMATION WAS THEN NOTICED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6188377 ↗
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- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 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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