HydroSoft 3D 100204HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777026507), received between May 21, 2020 and Dec 6, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Stretched; Physical Resistance/Sticking; Premature Separation; Stretched; Physical Resistance/Sticking; Premature Separation

  IT WAS REPORTED THAT THE COIL STRETCHED IN THE MICROCATHETER. ADDITIONAL INFORMATION INDICATED, WHILE PLACING THE COIL IN THE ANEURYSM, THE MICROCATHETER MOVED SLIGHTLY AGAINST THE ANEURYSM WALL, WHICH PREVENTED THE REST OF THE COIL BEING DEPLOYED. WHILE WITHDRAWING THE COIL BACK INTO THE MICROCATHETER, SLIGHT RESISTANCE WAS FELT INITIALLY, BUT THEN THIS EASED. IT WAS AT THIS POINT THE OPERATOR REALIZED (ASSUMED) THE COIL HAD STRETCHED, BUT HE CONTINUED TO PULL, CAUSING THE PUSHER WIRE AND COIL TO SEPARATE. NO PATIENT HARM WAS REPORTED. THE PATIENT WAS REPORTED FINE AND WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868564 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE EMBOLIZATION COIL WAS USED IN A PROCEDURE FOR THE TREATMENT OF AN ACOM ANEURYSM. THE COIL PREPARED AND ADVANCED INTO THE MICROCATHETER. WHILE ADVANCING THE COIL PHYSICIAN FELT SOME RESISTANCE AND WHEN THE PHYSICIAN ATTEMPTED TO PULL OUT THE COIL FROM THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE COIL AND MICORCATHETER WERE REMOVED FROM THE PATIENT AND A NEW SET OF COIL AND MICROCATHETER WERE USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447197 ↗
• MalfunctionFeb 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ICA ANEURYSM, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF AN EMBOLIZATION COIL IMPLANT INTO THE TREATMENT SITE. UNDER FLUOROSCOPY, THE COIL WAS FOUND TO BE WITHIN THE ANEURYSM PRIOR TO REACHING THE PROXIMAL WARNING MARKER OF THE DELIVERY PUSHER, WHICH IS LOCATED OUTSIDE OF THE PATIENT. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389330 ↗
• MalfunctionMay 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE CURRENT PATIENT'S CONDITION WAS REPORTED TO BE "NORMAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080787 ↗