ConcertoTM PV-5-15-3D (UDI 00847536033771)Recalls & reported problems
Micro Therapeutics, Inc. · COIL PV-5-15-3D V04 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536033771), received between Mar 7, 2022 and Nov 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Separation Failure1
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.
MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT DURING THE REMOVAL OF THE COIL CONCERTO 3D 5MM X 15CM FROM THE ANTERIOR TIBIAL ARTERY, THE MICROCATHETER COILS BROKE, RESULTING IN THE COILS REMAINING INSIDE THE CATHETER. THE PROCEDURE WAS CONDUCTED ON THE LEFT MID ANTERIOR TIBIAL ARTERY, WHICH HAD A DIAMETER OF 3MM AND A LESION LENGTH OF 40MM. THERE WAS NO TORTUOSITY OR CALCIFICATION NOTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE DEFECTIVE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800574 ↗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 13677920 ↗
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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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