Intuition INTU180HSRecalls & reported problems
Medtronic, Inc. · GDWR INTU180HS INTUITION 5PK 180 HY ST · Class 2
Data updated Oct 16, 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 00763000569952), received between May 1, 2024 and May 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, ONE INTUITION GUIDEWIRE, ONE NC EUPHORA BALLOON AND ONE LAUNCHER GUIDE CATHETER DURING A PROCEDURE. ALL DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON THE RESOLUTE ONYX AND NC EUPHORA DEVICES WITH NO ISSUES. THE INTUITION AND LAUNCHER DEVICES WERE PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE LAUNCHER DEVICE, AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE RESOLUTE ONYX STENT DISLODGED DURING DELIVERY TO THE LESION. THE STENT DISLODGED DURING PULL AND PUSH FACTOR OF THE INTUITION GUIDEWIRE, AND THE GUIDEWIRE BROKE IN HALF, POSSIBLY DUE TO CALCIFICATION. THE PATIENT WAS RECOMMENDED FOR SURGERY FOR REMOVAL OF THE GUIDEWIRE AND STENT, WHICH WERE REMOVED BY USING THE SNARE TECHNIQUE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.
Patient problems: Insufficient Information
MAUDE report 19220398 ↗
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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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