Integrity INT35030UXRecalls & reported problems
Medtronic, Inc. · Stent INT35030UX INTEGRITY 3.50X30UX · 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 00613994798602), received between Apr 24, 2017 and Apr 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2017Material Deformation; Material Deformation
THE PHYSICIAN INTENDED TO USE AN INTEGRITY BARE METAL STENT TO TREAT A LESION LOCATED IN THE PROXIMAL SAPHENOUS VEIN GRAFT . IT WAS REPORTED THAT THE LESION WAS SEVERELY TORTUOUS, SEVERELY CALCIFIED WITH 70% STENOSIS. IN STENT RESTENOSIS WAS NOTED. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STENT WOULD NOT CROSS THE LESION DESPITE MULTIPLE ATTEMPTS TO POSITION THE INTEGRITY STENT. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT HOWEVER RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE PHYSICIAN ALSO PRE-DILATED THE LESION THREE TIMES USING NC BALLOONS. PRIOR TO LAST ATTEMPT TO POSITION THE STENT, THE STENT HAD A 4X4 GAUZE LAYING ON IT. WHEN THE GAUZE WAS REMOVED IT CAUGHT ON THE STENT CAUSING IT TO BE STRETCHED AND DEFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6515569 ↗
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- 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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