Integrity INT35018UXRecalls & reported problems
Medtronic, Inc. · Stent INT35018UX INTEGRITY 3.50X18UX · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994798572), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN INTEGRITY BARE METAL STENT. NO DAMAGE WAS NOTED TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP / TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. LESION SITE WAS INTERNAL ILIAC, EXHIBITING 90% STENOSIS AND 45 DEGREE ANGLE. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH, NO ISSUES REPORTED. THE INFLATION DEVICE DID NOT REMAIN ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED AFTER GETTING CAUGHT ON PREVIOUSLY IMPLANTED STENTS IN PLACE. IT WAS REPORTED THAT NOTHING WOULD CROSS AND THE STENT HAD TO BE RETRIEVED USING A SNARE. NO CLINICAL SEQUELAE REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6236267 ↗
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
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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