ConcertoTM NV-3-4-HELIX (UDI 00847536013360)Recalls & reported problems
Micro Therapeutics, Inc. · NV-3-4-HELIX CONCERTO HELIX 3MMX4CM · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 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 00847536013360), received between Jul 19, 2019 and Nov 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT COIL DETACHED ITSELF DURING PREPARATION. NO FURTHER DETAILS WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9351865 ↗MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED REPORT THAT THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT GASTRIC ARTERY. IT IS UNKNOWN IF THE DEVICE WERE PREPARED AND USED EXACTLY AS PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH NEW DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8806885 ↗
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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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