Integrity INT22526UXRecalls & reported problems
Medtronic, Inc. · Stent INT22526UX INTEGRITY 2.25X26UX · 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 00613994798732), received between Jul 9, 2019 and Jul 9, 2019 — 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
- Fracture1
Patient problems
- Chest Pain1
- Device Embedded In Tissue or Plaque1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
DURING A PROCEDURE AN INTEGRITY RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FRACTURED INTO TWO PIECES ON ATTEMPT TO REMOVE THE STENT. ONE PORTION REMAINED IN THE PROXIMAL LAD WHERE IT WAS CRUSHED UP AGAINST THE ARTERY WALL. THE SECOND PORTION BECAME LODGED AT THE OSTIA LEFT MAIN WHERE IT REMAINS IMMOBILE. NO ATTEMPT TO SNARE WAS MADE FOR FEAR OF EMBOLIZATION. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Injury
MAUDE report 8771462 ↗
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- 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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