ConcertoTM PV-14-40-3D (UDI 00847536026506)Recalls & reported problems
Micro Therapeutics, Inc. · COIL PV-14-40-3D CONCERTO 3D V01 · 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 00847536026506), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED REPORT THAT DURING A RENAL STENT ASSISTED COILING PROCEDURE, PLACED TWO 14X40 3D COILS, 3RD 3D COIL 14X40 WENT OUTSIDE THE STENT. THE COIL WAS PULLED BACK GENTLY AND LITTLE POP WAS FELT. THE COIL WAS NOTED TO HAVE PREMATURELY DETACHED. THE COIL WAS SUCCESSFULLY RETRIEVED AND STRETCHED DURING THE RETRIEVAL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8308934 ↗
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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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