HydroSoft Helical 100208H2HS-V-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811425020173), received between Feb 3, 2021 and Apr 4, 2023 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryApr 4, 2023Separation Failure; Device Dislodged or Dislocated; Difficult or Delayed Separation; Premature Separation; Separation Failure; Device Dislodged or Dislocated; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT FOR AN RT P. COM ANEURYSM, THE COIL PREMATURELY DETACHED WITHIN THE CATHETER AFTER MULTIPLE FAILED ATTEMPTS WERE MADE TO DETACH IT. THE PHYSICIAN USED THE DELIVERY WIRE TO PUSH THE COIL INTO THE ANEURYSM, LEAVING A SMALL PROTRUDING LOOP AT THE ANEURYSM¿S NECK. THE DOCTOR DECIDED A STENT WAS NOT REQUIRED. THE COIL REMAINS IMPLANTED IN THE PATIENT. ASPIRIN 500MG IV WAS ADMINISTERED TO THE PATIENT. THE OPERATIVE REPORT WAS REQUESTED AND WAS REPORTED AS NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679069 ↗
• InjuryFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION TO TREAT AN ANEURYSM IN THE SUPERIOR CEREBELLAR ARTERY (SCA), THE EMBOLIZATION COIL DETACHED DURING RETRACTION WHILE REPOSITIONING. A STENT WAS DEPLOYED IN THE VERTEBRAL ARTERY TO SECURE THE COIL TAIL TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA. THE CURRENT CONDITION OF THE PATIENT IS REPORTED TO BE "STABLE, GOOD."

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276973 ↗