ConcertoTM PV-16-40-3D (UDI 00847536026513)Recalls & reported problems
Micro Therapeutics, Inc. · COIL PV-16-40-3D 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 00847536026513), received between Sep 17, 2019 and Sep 17, 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.
MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT THIS COIL DETACHED PREMATURELY DURING THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO DELIVER COIL AND WAS ADJUSTING THE PLACEMENT TO OPTIMIZE LOCATION WITHIN THE SAC OF THE ANEURYSM AND THE COIL SIMPLY DETACHED. THE COIL WAS PARTIALLY OUT OF THE MICROCATHETER AND PARTIALLY STILL INSIDE THE DELIVERY MICROCATHETER. THERE WAS NO KINK IN THE WIRE. THE PHYSICIAN PULLED NEGATIVE PRESSURE AND PULLED THE COIL AND MICROCATHETER OUT ALL TOGETHER. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9077585 ↗
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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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