Integrity INT35015UXRecalls & reported problems
Medtronic, Inc. · Stent INT35015UX INTEGRITY 3.50X15UX · 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 00613994798565), received between Jun 8, 2020 and Jun 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
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.
MalfunctionJun 8, 2020Use of Device Problem; Use of Device Problem
A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A NONE TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 98-99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A PATIENT EXPERIENCING SEVERE CHEST PAIN WITH DIAGNOSIS OF STEMI INFERIORLY WITH RECIPROCAL CHANGES WAS BROUGHT FROM ER TO THE CATH LAB FOR EVALUATION AND TREATMENT. A DIAGNOSTIC CORONARY ANGIOGRAPHY SHOWS 98-99% OCCLUDED RCA SECONDARY TO PLAQUE RUPTURE. A RESOLUTE INTEGRITY BARE METAL STENT WAS PLACED IN THE RIGHT CORONARY ARTERY WITH GOOD RESULTS AND PROMPT RESOLUTION OF SYMPTOMS. IT WAS REPORTED THAT THE PRODUCT WAS EXPIRED. THE EXPIRED PRODUCT WAS QUARANTINED WITHIN THE CATH LAB, HOWEVER WAS STILL ACCESSIBLE TO STAFF. STAFF PULLED AN EXPIRED BMS FROM QUARANTINED PILE FOR IMPLANT. NOTE, ROUTINE INVENTORY INSPECTION BY MDT REP HAVE BEEN RESTRICTED DUE TO COVID-19 ALLOWING NO ACCESS TO THE HOSPITAL STARTING MARCH 2020. THE PATIENT IS ALIV
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10128159 ↗
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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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