ConcertoTM NV-9-30-HELIX (UDI 00847536033603)Recalls & reported problems
Micro Therapeutics, Inc. · COIL NV-9-30-HELIX V06 · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 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 00847536033603), received between May 23, 2024 and May 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
- Separation Failure1
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.
MalfunctionMay 23, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE CONCERTO COIL WOULD NOT ENTER THE MICRO-CATHETER. IN ANOTHER ATTEMPT, THE DOCTOR WAS ABLE TO ADVANCE THE COIL INTO THE MICRO-CATHETER BUT IT WOULD NOT DETACH/SEPARATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382195 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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