Resolute Integrity™ RSINT30034UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT30034UX MicroTrac 3.00X34RX · 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 00643169037199), received between Jan 2, 2019 and Jan 2, 2019 — 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 18, 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.
MalfunctionJan 2, 2019Material Deformation; Material Deformation
A RESOLUTE INTEGRITY DRUG ELUTING STENT DEVICE WAS ATTEMPTED TO BE USED TO TREAT IN-STENT RESTENOSIS IN THE OM1. THE LESION WAS PRE-DILATED WITH A 2.75 X 15MM EUPHORA BALLOON CATHETER. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT STRUT DAMAGE WAS SEEN ON REMOVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC STENT. NO PATIENT INJURY IS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8208020 ↗
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- 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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