Integrity INT40018UXRecalls & reported problems
Medtronic, Inc. · Stent INT40018UX INTEGRITY 4.00X18UX · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994798640), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 death.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Detachment of Device or Device Component1
Patient problems
- Death1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 23, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 4.0 X 12 INTEGRITY BARE METAL STENT TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS OSTIUM OF THE LEFT MAIN CORONARY ARTERY AND CX. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE A CUTTING BALLOON WAS USED AND AN NC EUPHORA BALLOON WAS USED TO PRE-DILATE THE PROXIMAL CIRC AND ALSO TO SUPPORT ADVANCEMENT OF A NON MDT GUIDE EXTENSION CATHETER. THE GUIDE EXTENSION CATHETER WAS ADVANCED DISTAL TO THE LESION AND THE BALLOON WAS REMOVED. THE 4.0 X 12 INTEGRITY STENT WAS SUCCESSFULLY DELIVERED TO THE MID CIRC. THE 4.0 X 18 INTEGRITY STENT WAS INSERTED AND POSITIONED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE GUIDE EXTENSION CATHETER WAS PULLED BACK WHICH EXPOSED THE STENT AND THEN STENT DEPLOYMENT BEGAN. UPON INFLATING THE BALLOON DELIVERY SYSTEM TO APPROXIMATELY 7 ATM, RESISTANCE WAS LOST AND BLOOD TRAVELED BACK TO INFLATION DEVICE AND THE TECH REPORTED A BURST BALLOON. INITIALLY THE OPERATOR ATTEMPTED TO PULL BACK THE ENTIRE SYSTEM BUT IT WAS ¿STUCK¿ . A FEW SECONDS LATER AS THEY PULLED BACK AGAIN THE DELIVER Y SYSTEM WAS
Patient problems: Death; Device Embedded In Tissue or Plaque
MAUDE report 6352592 ↗
Other STENT, CORONARY devices
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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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