Integrity INT35012UXRecalls & reported problems
Medtronic, Inc. · Stent INT35012UX INTEGRITY 3.50X12UX · 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 00613994798558), received between Dec 14, 2017 and Dec 14, 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.
MalfunctionDec 14, 2017Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INTEGRITY RX CORONARY BARE METAL STENT TO TREAT A SEVERELY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM RIGHT CORONARY ARTERY, EXHIBITING 85% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS POSITION; THE STENT FAILED TO CROSS THE FIRST TIME. IT WAS REPORTED THAT THE STENT WOULD NOT CROSS BECAUSE THE GUIDE WASN'T THE CORRECT SIZE FOR THE ANATOMY. THE DOCTOR CHANGED OUT THE CATHETER AND WENT TO USE THE STENT AGAIN. THE PHYSICIAN NOTICED WHILE LOADING THE STENT ON THE WIRE THAT EITHER THE STENT STRUT WAS STICKING UP OR THERE WAS TISSUE ON THE STRUT. IT WAS REPORTED THAT IT WAS TOO SMALL TO TELL. THE PHYSICIAN DECIDED TO USE ANOTHER STENT INSTEAD AND IT WAS SUCCESSFULLY IMPLANTED. THE INTEGRITY RX STENT WENT INTO THE BODY ONCE. NO DISSECTION OR ANY A
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7116442 ↗
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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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