Resolute Integrity™ RSINT27512WRecalls & reported problems
Medtronic, Inc. · Stent RSINT27512W MicroTrac 2.75X12OTW · 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 00613994793492), received between Jul 6, 2017 and Jul 6, 2017 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY STENT IN A LESION IN THE LAD WHICH HAD MODERATE CALCIFICATION AND TORTUOSITY. NO DAMAGE WAS NOTED TO THE PACKAGING AND THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL AFTER FAILED DELIVERY. THE DISLODGED STENT REMAINS IN PATIENT AND NO OTHER STENT WAS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6688837 ↗
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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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