Integrity INT30030WRecalls & reported problems
Medtronic, Inc. · Stent INT30030W INTEGRITY 3.00X30W · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994602343), received between Dec 20, 2016 and Sep 18, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2017Material Deformation; Material Deformation
THE PHYSICIAN INTENDED TO USE AN INTEGRITY BARE METAL STENT TO TREAT A LESION IN THE MID CX ARTERY, EXHIBITING MODERATE TORTUOSITY, MODERATE CALCIFICATION AND CHRONIC TOTAL OCCLUSION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS NOTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT IS REPORTED AS ALIVE, NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6871949 ↗MalfunctionDec 20, 2016Material Deformation; Material Deformation
THE PHYSICIAN INTENDED TO USE AN INTEGRITY DEVICE, IN A RCA LESION WITH SEVERE CALCIFICATION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. ATHERECTOMY AND SEVERAL NC BALLOON INFLATIONS WERE CARRIED OUT. HOWEVER, IT IS REPORTED THAT THE INTEGRITY DEVICE FAILED TO CROSS AND STENT DAMAGE WAS NOTED. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6189166 ↗
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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
- 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.
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