ConcertoTM PV-14-30-HELIX (UDI 00847536016996)Recalls & reported problems
Micro Therapeutics, Inc. · PV-14-30-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
- 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 00847536016996), received between Dec 14, 2018 and Dec 14, 2018 — 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2018Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
MEDTRONIC RECEIVED A REPORT THAT, WHILE ADVANCING THE COIL INTO THE SUPPORT CATHETER AFTER FLUSHING, IT BECAME DISLODGED/DETACHED IN THE CATHETER AND STRAIGHTENED/STRETCHED. AS A RESULT THE PHYSICIAN REMOVED THE COIL AND REPLACED WITH THAT OF ANOTHER MANUFACTURER. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BLEED. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS NORMAL. THE PHYSICIAN DID NOT REPOSITION/ROTATE THE COIL, NOR DID THEY ATTEMPT TO DETACH THE COIL. A CONTINUOUS FLUSH WAS USED THROUGHOUT THE PROCEDURE. THERE WERE NO RELATED PATIENT SYMPTOMS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8165273 ↗
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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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