Integrity INT22508UXRecalls & reported problems
Medtronic, Inc. · Stent INT22508UX INTEGRITY 2.25X08UX · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994798688), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 injury.
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
- 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.
InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY BARE METAL STENT TO TREAT A SEVERELY TORTUOUS, NON-CALCIFIED LESION IN THE LEFT MID CEREBRAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. 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 WHILE ATTEMPTING TO DEPLOY THE STENT IN THE LEFT MID CEREBRAL ARTERY THAT RESISTANCE WAS MET AND THE STENT COULD NOT REACH THE LESION. WHILE REMOVING THE STENT AND CATHETER AS A UNIT, RESISTANCE WAS ENCOUNTERED AND FOLLOWING A TUG ON THE STENT, THE STENT DISLODGED INTO THE CAROTID ARTERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO FURTHER INJURY POST PROCEDURE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8173804 ↗
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- 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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