HydroSoft Helical 100620H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777021649), received between Apr 1, 2020 and Dec 12, 2023 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT THE COIL WAS INSERTED INTO THE HEADWAY AND RESISTANCE WAS FELT. THE COIL WAS NOT ABLE COME OUT OF THE HEADWAY. THEREFORE, THE PHYSICIAN PULLED OUT THE COIL AND THE MICROCATHETER AND THE COIL WAS OBSERVED TO BE DAMAGED. THE COIL WAS REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313569 ↗
• InjuryApr 1, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL IN THE ANEURYSM, THE COIL WAS WITHDRAWN BACK INTO THE MICROCATHETER THREE (3) TIMES FOR REPOSITIONING AND THEN IT UNEXPECTEDLY DETACHED. THE DETACHED COIL SEGMENT WAS RETRIEVED WITH A SOLITAIRE STENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913732 ↗