Integrity INT30015UXRecalls & reported problems
Medtronic, Inc. · Stent INT30015UX INTEGRITY 3.00X15UX · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994798497), received between Nov 30, 2018 and Mar 13, 2019 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
- Rash1
- Reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT PREVIOUSLY IMPLANTED WITH AN INTEGRITY RX CORONARY BARE METAL STENT QUERIED WHAT THE STENT WAS MADE OF. IT WAS REPORTED THAT SINCE HAVING THE STENT IMPLANTED THAT ITCHING HAS OCCURRED AND AN OCCASIONAL RASH. SYMPTOMS BEGAN WITHIN HOURS OF HAVING THE STENT IMPLANTED. THE PATIENT ALSO STARTED A BLOOD THINNER AT THE TIME OF IMPLANT AND IS TRYING TO DETERMINE IF THE MEDICATION OR STENT IS CAUSING THE SYMPTOMS. THE PATIENT REPORTS WORKING WITH A DERMATOLOGIST TO DETERMINE THE CAUSE OF ITCHING AND STATES THAT THE DERMATOLOGIST WANTED TO KNOW WHAT THE STENT WAS MADE OUT OF. THE MATERIAL SPECIFICATIONS OF THE STENT WERE EXPLAINED TO THE PATIENT.
Patient problems: Rash; Reaction
MAUDE report 8416052 ↗MalfunctionNov 30, 2018Material Deformation; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY BARE METAL STENT TO TREAT A VERY CALCIFIED LESION LOCATED IN THE DISTAL CIRCUMFLEX (CX) ARTERY. NEGATIVE PREP WAS PERFORMED. THE HOOP WAS NOT FLUSHED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO CROSS THE VERY CALCIFIED LESION AND WAS REMOVED FROM THE PATIENT. IT WAS OBSERVED ON REMOVAL OF THE STENT FROM THE PATIENT THAT ONE OF THE STRUTS WAS RAISED UP. THE PROCEDURE WAS COMPLETED BY PRE-DILATING WITH A 2.5X15MM BALLOON AND IMPLANTING ANOTHER 3.0X15MM STENT. NO PATIENT INJURY IS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8119332 ↗
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- 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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