Concerto Detachable Coil System PV-7-30-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL PV-7-30-3D 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
- 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 00847536045170), received between Apr 4, 2024 and Apr 4, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE COIL DETACHING INVOLUNTARILY. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THERE WERE NO DETACHMENT ATTEMPTS. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION AS IT WAS ATTEMPTED TO DETACH UNSUCCESSFULLY AND THEN IT DETACHED INSIDE THE MICROCATHETER. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED DUE TO COIL IMPLANTATION IN AN UNINTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042090 ↗
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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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