Resolute Integrity™ RSINT25030WRecalls & reported problems
Medtronic, Inc. · Stent RSINT25030W MicroTrac 2.50X30OTW · Class 3 · Implant
Data updated Oct 13, 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 00613994793270), received between Apr 7, 2017 and Apr 7, 2017 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionApr 7, 2017Material Deformation; Material Deformation
IT IS REPORTED THAT DURING USE, THE RESOLUTE INTEGRITY DRUG-ELUTING STENT (DES) BECAME DAMAGED WHEN TRYING TO PLACE IT IN THE DIAGONAL VESSEL. DEVICE WAS INSPECTED PRIOR TO USE , NO ISSUES NOTED. LESION WAS PRE-DILATED. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTE DES AFTER ANCHORING A BALLOON IN THE LAD. THE BALLOON ENABLED THE NEW STENT TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6471190 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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