Resolute Integrity™ RSINT40030UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT40030UX MicroTrac 4.00X30RX · Class 3 · Implant
All models of Resolute Integrity (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037243), received between Apr 27, 2017 and Dec 15, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
Patient problems
- Myocardial Infarction1
- No Consequences Or Impact To Patient1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD. APPROXIMATELY TWO WEEKS LATER DURING A STAGED PROCEDURE, ANGIOGRAPHY AND REVASCULARIZATION WERE PERFORMED AND A RESOLUTE INTEGRITY DES WAS IMPLANTED IN THE RCA. CEC ADJUDICATED THAT NON-TARGET VESSEL MI AND SIDE BRANCH OCCLUSION OF THE RCA OCCURRED POST STAGED PROCEDURE.
Patient problems: Myocardial Infarction; Obstruction/Occlusion
MAUDE report 11011470 ↗MalfunctionApr 27, 2017Difficult to Remove; Difficult to Remove
THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM GOT STUCK INSIDE THE PRESSURE WIRE AND THE TIP OF THE WIRE WAS NOT ABLE TO BE REMOVED FROM THE RX PORT OF THE STENT BALLOON. THIS HAPPENED WHEN STAFF TRIED TO REMOVE THE STENT DELIVERY SYSTEM AFTER STENT DEPLOYMENT. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6525497 ↗
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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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