Resolute Integrity™ RSINT40009UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT40009UX MicroTrac 4.00X9RX · Class 3 · Implant
All models of Resolute Integrity (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037304), received between Apr 19, 2018 and Aug 12, 2020 — classified as 1 death, 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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Difficult to Remove1
Patient problems
- Blood Loss1
- Death1
- Inflammation1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE, TWO RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS. IT WAS REPORTED THAT THE PATIENT DECEASED 5 YEARS POST IMPLANTATION OF THE RESOLUTE INTEGRITY STENTS. IT WAS STATED THAT THE CAUSE OF DEATH WAS CHOLECYSTITIS.
Patient problems: Death; Inflammation
MAUDE report 10395002 ↗InjuryApr 19, 2018Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated
A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS BEING USED TO TREAT A LESION IN A PATIENT. IT WAS REPORTED THAT THE STENT BECAME STUCK, CAUGHT IN HEART. THE PATIENT HAD TO BE TRANSPORTED TO ANOTHER FACILITY WHERE AN EMERGENCY TRIPLE BYPASS SURGERY WAS CARRIED OUT. ANOTHER STENT WAS ALSO PLACED DURING THIS SURGERY. DUE TO THE LOSS OF BLOOD, THE PATIENT REQUIRED A BLOOD TRANSFUSION. PATIENT STATED THAT THEY ARE ON EDGE FOLLOWING THE PROCEDURE AND THAT SCARS ARE PRESENT ON THEIR LEGS DUE TO GRAPHS BEING REQUIRED DURING THE SURGERY.
Patient problems: Blood Loss; Patient Problem/Medical Problem
MAUDE report 7442386 ↗
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- 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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