ConcertoTM PV-3-8-3D (UDI 00847536026339)Recalls & reported problems
Micro Therapeutics, Inc. · COIL PV-3-8-3D V01 CONCERTO 3D · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536026339), received between May 15, 2019 and Oct 20, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Physical Resistance/Sticking2
- Premature Separation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS STUCK IN THE PROTECTIVE SHEATH. NO DAMAGE WAS OBSERVED. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED IN DURING HYDRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665764 ↗MalfunctionOct 20, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS STUCK IN THE PROTECTIVE SHEATH. NO DAMAGE WAS OBSERVED. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED IN DURING HYDRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665655 ↗MalfunctionSep 10, 2019Premature Separation; Premature Separation
MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS ENCOUNTERED WHEN THE CONCERTO COIL WAS ADVANCED THROUGH THE RENEGADE CATHETER. THE DEVICE DID NOT EXIT THE MICROCATHETER. A CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDE A RENEGADE STRAIGHT .021.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8982788 ↗MalfunctionMay 15, 2019Separation Failure; Separation Failure
MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER. THE COIL WAS REPLACED WITH A COIL FROM ANOTHER MANUFACTURE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8612757 ↗
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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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