Integrity INT30022WRecalls & reported problems
Medtronic, Inc. · Stent INT30022W INTEGRITY 3.00X22W · Class 3 · Implant
Data updated Oct 13, 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 00613994602374), received between Jan 5, 2018 and Jan 5, 2018 — classified as 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
- Material Deformation1
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.
MalfunctionJan 5, 2018Material Deformation; Material Deformation
PHYSICIAN WAS ATTEMPTING TO TREAT AN IN-STENT RESTENOSIS LESION IN THE LAD USING INTEGRITY BARE METAL STENT (BMS). THE DEVICE WAS PREPPED PRIOR TO USE. THE DEVICE WAS INSPECTED PRIOR TO USE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING USE THE STRUTS WERE DAMAGED. THE DEVICE WAS TRYING TO PASS THROUGH A PREVIOUSLY DEPLOYED NON MEDTRONIC STENT WHICH HAD IN-STENT RESTENOSIS WHEN THE DAMAGE TO THE STENT STRUTS OCCURRED. PATIENT STATUS POST PROCEDURE IS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7166983 ↗
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- 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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