Concerto Detachable Coil System PV-2-2-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL PV-2-2-3D V05 · Class 2 · Implant
All models of Concerto Detachable Coil System (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536045071), received between Jun 16, 2025 and Mar 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking2
- Detachment of Device or Device Component1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Physical Resistance/Sticking
MEDTRONIC RECEIVED REPORT REGARDING CONCERTO COIL THAT HAD RESISTANCE/WAS STUCK IN THE SHEATH. FURTHERMORE, IT WAS REPORTED THAT THE COIL BECAME ENTANGLED WITH THE MICROCATHETER AND DAMAGED IT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. (B)(6) 2026 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION; THE DEVICE WAS HELD HORIZONTALLY. THE COIL NEVER ENTERED THE MICROCATHETER OR THE PATIENT'S BODY. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ANCILLARY DEVICE: TERUMO PROGREAT 2.4F CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618934 ↗MalfunctionJun 16, 2025Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT WHEN THE DOCTOR PUT THE SHEATH INTO THE HUB OF THE TRUSELECT MICROCATHETER, THE CONCERTO COIL CAME OUT AND IMMEDIATELY FORMED A COIL MESH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214575 ↗
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