Integrity INT22522UXRecalls & reported problems
Medtronic, Inc. · Stent INT22522UX INTEGRITY 2.25X22UX · Class 3 · Implant
All models of Integrity (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994798725), received between Jun 7, 2018 and Nov 26, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 Dislocated2
Patient problems
- No Consequences Or Impact To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY BARE METAL STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED IN THE LM DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS JAILED USING A NON MEDTRONIC PERIPHERAL STENT IN THE LEFT ILIAC. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9375668 ↗InjuryJun 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN INTEGRITY BARE METAL STENT WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO GET THE STENT DELIVERY SYSTEM AROUND A TORTUOUS CURVATURE OF THE CORONARY ARTERIES BUT WAS UNSUCCESSFUL. WHEN THE PHYSICIAN RETRACTED THE DELIVERY SYSTEM BACK INTO THE GUIDE CATHETER, THE STENT DISLODGED. THE ENTIRE DELIVERY SYSTEM, INCLUDING THE SHEATH, WAS REMOVED. THE STENT WAS RETAINED IN THE RADIAL ARTERY AT THE ACCESS SITE. THE STENT WAS REMOVED LATER THAT SAME DAY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7576881 ↗
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- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- 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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