HydroSoft 3D 100310HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816777026590), received between May 16, 2019 and Jul 17, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2024Positioning Problem; Positioning Problem

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767837 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  IT WAS REPORTED THE PHYSICIAN WAS TREATING A 10 MM ICA TOP ANEURYSM WITH A STENT AND ASSISTED COILING. HE WAS USING THE LAST COIL AND WHEN MANEUVERING IT, OBSERVED THAT THE COIL HAD DETACHED SPONTANEOUSLY. SINCE IT WAS THE LAST COIL, THE PHYSICIAN DECIDED TO REMOVE IT ALONG WITH THE MICROCATHETER. PROCEDURE WAS COMPLETED AND THE PATIENT IS STABLE, DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771705 ↗
• MalfunctionJul 13, 2022Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A PCOM ANEURYSM, TWO COILS PREMATURELY DETACHED FROM THE DELIVERY PUSHERS. NO PATIENT HARM OR INTERVENTION WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THIS REPORT ADDRESSES THE FIRST COIL. THE OTHER COIL IS REFERENCED UNDER MFR REPORT # 2032493-2022-00277.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008258 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED FOR TREATMENT OF UNSPECIFIED ANEURYSM. WHEN ROUGHLY 7CM OF THE COIL WAS DEPLOYED IN THE ANEURYSM, RESISTANCE FELT AND THE COIL STRETCHED. THE PUSHER DETACHED IN THE MICROCATHETER DURING ATTEMPT TO REMOVE THE COIL. THE COIL WAS REMOVED ALONG WITH THE MICROCATHETER. OTHER COILS WERE USED TO SUCCESSFULLY COMPLETE THE CASE. PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315500 ↗
• MalfunctionJun 2, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL APPEARED TO DETACH; HOWEVER, IT ACTUALLY DETACHED WITHIN THE MICROCATHETER WHILE REMOVING THE DELIVERY SYSTEM. THE COIL AND MICROCATHETER WERE WITHDRAWN AS A SYSTEM WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER COILS. THE PATIENT AWOKE FROM THE PROCEDURE WITH NO ISSUES. THERE WAS NO REPORT OF INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926048 ↗
• MalfunctionNov 16, 2020Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, THE COIL DID NOT DETACH. DURING THE REMOVAL ATTEMPT, THE IMPLANT COIL STRETCHED AND DETACHED WITHIN THE BLOOD VESSEL DUE TO ALLEGEDLY FORCEFUL REMOVAL. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S CONDITION IS REPORTED TO BE "NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844687 ↗
• MalfunctionMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF THE 4TH EMBOLIZATION COIL IN AN ANEURYSM, THE COIL BEGAN TO STRETCH. DURING REMOVAL OF THE DEVICE, THE IMPLANT COIL DETACHED FROM THE PUSHER INSIDE THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10050123 ↗
• InjuryMay 16, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ATTEMPT TO RE-SHEATH THE COIL INTO THE MICROCATHETER, THE COIL STRETCHED AND DETACHED AT THE DETACHMENT POINT. A SOLITAIRE STENT WAS USED TO SUCCESSFULLY RETRIEVE THE COIL INTO A SOFIA CATHETER. THE PATIENT WOKE WITH HEMIPARESIS; HOWEVER, NO BLEEDING OR CLOT COULD BE IDENTIFIED ON CT SCAN. DURING FOLLOW-UP THE NEXT MORNING ON (B)(6) 2019, THE PATIENT WAS REPORTED TO HAVE MOSTLY RECOVERED FROM THE HEMIPARESIS AND IS DOING WELL.

  Patient problems: Paresis

  MAUDE report 8616695 ↗