Concerto Versa™ CV-4-15 (UDI 00763000936624)Recalls & reported problems
Medtronic, Inc. · COIL CONCERTO VERSA CV-4-15 · Class 2 · Implant
Data updated Oct 16, 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 00763000936624), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Physical Resistance/Sticking1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Difficult to Advance; Physical Resistance/Sticking; Premature Separation
It was reported that during treatment for ¿Hypo take down,¿ a CONCERTO VERSA coil was prepared as indicated in the instructions for use and tracking difficulty occurred during initial advancement and resistance/sticking occurred in the catheter at the hub. Physician hubbed introducer sheath to catheter and felt resistance advancing into a 2.8 non-Medtronic microcatheter. Physician pulled back and tried to re-advance and felt resistance again. When physician pulled coil back , the coil had prematurely detached inside the microcatheter. The pusher release wire was bent/broken. The detached coil was removed from the patient. A replacement Concerto Versa CV-3-15 coil was used to complete the procedure and the issue was resolved. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880892 ↗
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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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