Resolute Integrity™ RSINT35034UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT35034UX MicroTrac 3.50X34RX · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169037281), received between May 30, 2019 and May 30, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
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.
MalfunctionMay 30, 2019Leak/Splash; Leak/Splash
AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT DURING THE PROCEDURE, A LEAK WAS DETECTED IN THE DEVICE WHEN NEGATIVE PRESSURE WAS PULLED. WHEN GETTING READY TO DEPLOY THE STENT IN THE BODY, AIR WAS NOTED WHEN PULLING BACK ON THE INDEFLATOR. THE STOPCOCK WAS THEN CLOSED OFF TO THE PATIENT AND THE STENT WAS REMOVED FROM THE BODY, REMOVING ALL AIR. MORE AIR WAS NOTED DURING WITHDRAWAL. ANOTHER RESOLUTE INTEGRITY STENT WAS THEN USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8653562 ↗
Other Coronary drug-eluting stent devices
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- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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