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Complex Helical - 18 M0013120550Recalls & reported problems

Boston Scientific Corporation · Fibered Platinum Coil · Class 2 · Implant

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 08714729324072), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Remove1

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.

  • MalfunctionMar 24, 2022Difficult to Remove; Difficult to Remove

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02MAR2022. IT WAS REPORTED THAT THE COIL GOT STUCK. A 8MMX12MM COMPLEX HELICAL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE PUSHING THE 8MMX12MM COMPLEX HELICAL WITH WIRE, IT WAS NOTED THAT THE COIL GOT STUCK WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13897204 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.