Resolute Integrity™ RSINT27508UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT27508UX MicroTrac 2.75X8RX · Class 3 · Implant
All models of Resolute Integrity (52)
Data updated Oct 16, 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 00643169037533), received between Dec 15, 2017 and Dec 15, 2017 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionDec 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE PHYSICIAN FELT RESISTANCE WHEN INITIALLY ADVANCING STENT THROUGH GUIDE. HE THEN REMOVED SYSTEM AND NOTICED A FRACTURE IN THE PROXIMAL SHAFT OF THE CATHETER. THE DEVICE BROKE IN TWO. IT WAS MENTIONED THAT THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT AND WAS REMOVED THROUGH GUIDE. THE STENT BALLOON WAS NOT INFLATED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7120694 ↗
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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 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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