HydroSoft Helical 100410H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777022967), received between Apr 19, 2019 and Feb 3, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE TO TREAT A 8.5MMX4MM PCM ANEURYSM, THE EMBOLIZATION COIL WAS USED AS A FILLING COIL, BUT WHILE PUSHING THE COIL INSIDE THE ANEURYSM, THE COIL UNINTENTIONALLY GOT DETACHED INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. A NEW SET OF COIL AND MICROCATHETER WERE USED TO SUCCESSFULLY COMPLETE THE CASE. POST PROCEDURE RUNS WERE NORMAL AND THERE WAS NO FILLING OF ANEURYSM. THE PATIENT WAS EXTUBATED AND SHIFTED TO ICU FOR FURTHER OBSERVATION. NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447092 ↗
• MalfunctionMay 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS SUCCESSFULLY PLACED IN AN ANEURYSM. HOWEVER, WHEN A SECOND DEVICE WAS BEING ADVANCED WITHIN THE MICROCATHETER, IT WAS NOTICED THAT A FRAGMENT OF THE FIRST COIL PLACED WAS OCCLUDING THE LUMEN OF THE MICROCATHETER. THE COIL FRAGMENT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED INJURY OR INTERVENTION. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882242 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR AN UNRUPTURED ANEURYSM, THE COIL DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533834 ↗