Integrity INT40015UXRecalls & reported problems
Medtronic, Inc. · Stent INT40015UX INTEGRITY 4.00X15UX · 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 00613994798633), received between Aug 14, 2017 and Aug 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionAug 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN INTENDED TO USE AN INTEGRITY BARE METAL STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. IT IS REPORTED THAT THE STENT SHAFT SEPARATED. THE DETACHMENT OCCURRED DURING ADVANCEMENT OF THE DEVICE. THE DETACHMENT OCCURRED ON THE PROXIMAL SHAFT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY OF THE DEVICE TO THE LESION SITE. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT BY REMOVING THE GUIDE. THE STENT WAS REPLACED WITH ANOTHER MDT STENT. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6790986 ↗
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page