ConcertoTM PV-12-40-HELIXRecalls & reported problems
Micro Therapeutics, Inc. · PV-12-40-HELIX CONCERTO PGLA COIL · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536016972), received between Dec 7, 2018 and May 10, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- Separation Failure1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2021Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DEPLOYED INCORRECTLY. IT WAS REPORTED THAT THE DEVICE FAILED AND MALFUNCTIONED. THE PATIENT WAS UNDERGOING TREATMENT FOR HYPOGASTRIC ARTERY EMBOLIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803335 ↗InjuryDec 7, 2018Migration; Migration
MEDTRONIC RECEIVED INFORMATION THAT COIL MIGRATION AFTER 3 MONTHS COILING PROCEDURE. IT WAS REPORTED THAT PATIENT WAS TREATED WITH CONCERTO COIL FOR A GONADAL EMBOLIZATION. 3 MONTHS AFTER, THE PATIENT WENT TO THE HOSPITAL WITH RESPIRATORY DISTRESS; THE X-RAY SHOWED A COIL DEVICE INSIDE THE LEFT LUNG.
Patient problems: Foreign Body In Patient
MAUDE report 8142912 ↗
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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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