ConcertoTM PV-4-12-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL PV-4-12-3D V04 · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536033764), received between Sep 25, 2020 and Sep 30, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Separation Failure2
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2024Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED REPORTED A FEW ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER. NO ATTEMPTS WERE MADE TO DETACH WITH THE MANUAL METHOD. THERE WERE NO ISSUES PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER IT WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339074 ↗MalfunctionMar 7, 2022Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT OF TWO CONCERTO COILS NOT DEPLOYING AND BECOMING ENTANGLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13677896 ↗MalfunctionSep 25, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL MET RESISTANCE IN THE DISTAL END OF THE RENEGADE STC 18 MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 15MM X 8MM LOCATED IN THE SPLENIC ARTERY. THE BLOOD FLOW WAS NORMAL, AND THE VASCULATURE WAS MODERATE. THERE ARE NO IMAGES FOR REVIEW. THERE WAS NO DAMAGED OBSERVED ON THE MICROCATHETER OR THE COIL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10589075 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page