Integrity INT22514UXRecalls & reported problems
Medtronic, Inc. · Stent INT22514UX INTEGRITY 2.25X14UX · Class 3 · Implant
All models of Integrity (27)
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 00613994798701), received between Dec 2, 2016 and Dec 2, 2016 — 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
- No Consequences Or Impact To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT 90% OSTIAL RIGHT CORONARY ARTERY STENOSIS AND AN 80% MID RIGHT CORONARY ARTERY STENOSIS AND HEAVILY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN SELECTED AN INTEGRITY 2.25X12MM STENT. NO DAMAGE NOTED TO DEVICE PACKAGING OR ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. DURING THE PROCEDURE THE LESION WAS PRE-DILATED PRIOR TO ATTEMPT TO IMPLANT STENT. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL FOLLOWING FAILED DELIVERY AND WAS RETRIEVED BY SNARE. IT WAS REPORTED THAT THE PHYSICIAN SELECTED ANOTHER INTEGRITY 2.25X14MM STENT TO CONTINUE THE PROCEDURE. NO DAMAGE NOTED TO DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT FELL OFF IN THE AORTA AND AN ATTEMPT WAS MADE TO SNARE THE STENT BUT WAS UNSUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem
MAUDE report 6140597 ↗
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- PALMAZ Balloon Expandable Stent P308Cordis US Corp. · STENT, CORONARY7 reports
- Cobra PzF 170-03-35024Celonova Biosciences, Inc. · Stent, Coronary7 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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