HydroSoft 3D 100154HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777026477), received between Mar 21, 2019 and Jun 10, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, AN EMBOLIZATION COIL IMPLANT APPEARED SHORTER IN LENGTH THAN EXPECTED WHEN ADVANCED THROUGH A MICROCATHETER. THE COIL WAS THEN WITHDRAWN AND REMOVED FROM THE PATIENT AND ANOTHER COIL WAS USED TO CONTINUE THE PROCEDURE. WHICH WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980379 ↗
• MalfunctionJun 2, 2021Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, AN EMBOLIZATION COIL IMPLANT DID NOT DETACH. UPON RETRACTION OF THE DEVICE, THE IMPLANT AND DELIVERY PUSHER BEGAN TO STRETCH AND THE IMPLANT DETACHED IN THE GUIDING CATHETER. THE PHYSICIAN SUCCESSFULLY PUSHED THE COIL INTO THE ANEURYSM USING A 0.35" WIRE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT IS REPORTED TO BE "OKAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926050 ↗
• MalfunctionMar 21, 2019Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING BALLOON-ASSISTED COIL EMBOLIZATION OF A SMALL, WIDE NECK MIDDLE CEREBRAL ARTERY ANEURYSM, THE COIL WOULD NOT STAY IN THE ANEURYSM DURING POSITIONING. DURING REMOVAL, THE COIL STRETCHED AT THE HUB OF THE MICROCATHETER AND THEN DETACHED FROM THE PUSHER WIRE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED A FEW DAYS POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441767 ↗