ConcertoTM PV-2-4-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL PV-2-4-3D V04 · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 16, 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 00847536033702), received between May 13, 2022 and Dec 29, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Compatibility Problem1
- Physical Resistance/Sticking1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2022Compatibility Problem; Compatibility Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT AT ALL AFFECTED BY THE PROBLEM.
Patient problems: Insufficient Information
MAUDE report 16069173 ↗MalfunctionJul 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MEDTRONIC RECEIVED A REPORT THAT 3 CONCERTO COILS WERE "DEFECTIVE" AND WERE NOT IMPLANTED. THERE WERE NO ABNORMALITIES RELATED TO THE PATIENT'S ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14988422 ↗MalfunctionMay 13, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WITH 4 CONCERTO COILS AND THE COIL WOULDN'T DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR PROSTATIC ARTERY EMBOLIZATION (PAE). THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT TWO COILS WERE STUCK IN THE PROXIMAL PART OF THE MICROCATHETER, ONE WAS STUCK IN THE CATHETER HUB, AND ONE WAS STUCK IN THE DISTAL PART OF THE CATHETER. THE COILS HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO DAMAGE TO THE CATHETER OR COILS. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14399445 ↗
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
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt 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 16, 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