Resolute Integrity™ RSINT40018UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT40018UX MicroTrac 4.00X18RX · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169037212), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE DISTAL INFRA-POPLITEAL ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A DETACHMENT OCCURRED AT THE CATHETER, DURING DELIVERY OF THE DEVICE THROUGH THE VESSEL. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13440954 ↗
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- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
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- 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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