HydroSoft Helical 100206H2HS-V-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811425020166), received between May 8, 2019 and Oct 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

Recent adverse event reports

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

• MalfunctionOct 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT BECAME DETACHED IN THE MICROCATHETER. THE IMPLANT WAS DELIVERED WITHOUT DIFFICULTY TO THE INTENDED TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY ON INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9242311 ↗
• MalfunctionMay 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  T WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE LAST COIL WAS FULLY DEPLOYED, HOWEVER IT WAS DETERMINED THAT THE LAST 2 LOOPS OF THE COIL COULD BE POSITIONED MORE DESIRABLY. AT THAT POINT, IT WAS OBSERVED THAT THE COIL HAD DETACHED FROM THE DELIVERY PUSHER WITHIN THE ANEURYSM. NO PORTION OF THE COIL LOOPS WERE PROTRUDING INTO THE PARENT VESSEL. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593174 ↗