Integrity INT40009UXRecalls & reported problems
Medtronic, Inc. · Stent INT40009UX INTEGRITY 4.00X09UX · 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 00613994798619), received between Sep 19, 2018 and Oct 10, 2018 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Myocardial Infarction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE, A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS POST PROCEDURE, A REVASCULARIZATION WAS CARRIED OUT DURING WHICH TWO INTEGRITY BARE METAL STENTS WERE IMPLANTED IN THE LCX. THE FOLLOWING DAY, THE PATIENT SUFFERED TROPONIN ELEVATION. CEC ADJUDICATED EVENT AS A NON-Q-WAVE MI OF NON-TARGET VESSEL. CEC ALSO ADJUDICATED STENT THROMBOSIS AS NON-EVENT.
Patient problems: Myocardial Infarction
MAUDE report 7951663 ↗InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE, A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROX. 35 MONTHS POST INDEX PROCEDURE, TWO INTEGRITY BARE METAL STENTS WERE IMPLANTED IN THE CX. ONE DAY POST IMPLANT OF THE INTEGRITY BARE METAL STENTS, TROPONIN ELEVATION WAS REPORTED. CEC ADJUDICATED THE EVENT AS NON-Q WAVE MI OF THE NON-TARGET VESSEL.
Patient problems: Myocardial Infarction
MAUDE report 7888485 ↗
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