HydroSoft Helical 100520H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023018), received between Oct 28, 2018 and May 28, 2026 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE EMBOLIZATION COIL IMPLANT WAS INTRODUCED INTO THE MICROCATHETER AND POSITIONED WITHIN THE ANEURYSM, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE DETACHMENT DEVICE. AT THAT POINT, IT BECAME APPARENT THAT THE PROXIMAL END OF THE DELIVERY PUSHER DESIGNED TO BE INSERTED INTO THE DETACHMENT DEVICE WAS MISSING. AS A RESULT, THE COIL HAD TO BE WITHDRAWN FROM THE ANEURYSM BACK INTO THE MICROCATHETER AND SUBSEQUENTLY REMOVED COMPLETELY FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH THE NEW COIL. THE BROKEN OR MISSING PART OF THE PUSHER WAS OUTSIDE OF THE PATIENT'S BODY. THE WAS NO PATIENT INJURY AND THEIR CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323333 ↗
• InjuryMar 27, 2021Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT UPON REMOVING THE DELIVERY PUSHER FROM THE DISPENSER HOOP, THE DELIVERY PUSHER WAS OBSERVED TO BE BENT. THE DEVICE PASSED THE PRE-TEST. DURING POSITIONING, THE IMPLANT COIL DETACHED FROM THE DELIVERY PUSHER. THE COIL WAS REMOVED SUCCESSFULLY USING AN ENDOVASCULAR SNARE. THE PATIENT WAS REPORTED TO BE "GOOD." THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579782 ↗
• InjuryOct 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS BEING PLACED INTO THE EXISTING COIL BALL. DURING REPOSITIONING AND RETRACTION, THE COIL DETACHED, LEAVING APPROXIMATELY 6 CM OF UNDEPLOYED COIL IN THE MICROCATHETER. THE DETACHED COIL WAS SUCCESSFULLY REMOVED WITH AN ALLIGATOR RETRIEVAL DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE ISSUE AND THE PATIENT HAS HAD NO ADVERSE SYMPTOMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8011166 ↗