HydroSoft 3D 100308HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777026583), received between Aug 7, 2019 and Feb 2, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED FROM THE PUSHER WIRE, WITHOUT THE USE OF THE V-GRIP CONTROLLER. THE COIL WAS RETRIEVED FROM THE PATIENT AND FINISHED THE TREATMENT SUCCESSFULLY, BY USING OTHER COILS. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283949 ↗
• MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  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 SECOND COIL. THE FIRST COIL IS REFERENCED UNDER MFR REPORT # 2032493-2022-00276.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008381 ↗
• InjuryAug 18, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL, THE COIL STRETCHED AS IT WAS PULLED. THE COIL DETACHED FROM THE DELIVERY PUSHER WITHIN THE PARENT VESSEL. THE COIL WAS FIXED IN PLACE USING TWO STENTS DISTAL AND PROXIMAL TO THE COIL AS THE COIL COULD NOT BE WITHDRAWN. NO PATIENT HARM OR INJURY WAS REPORTED. THE PATIENT'S OUTCOME WAS REPORTED TO BE "GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340236 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Environmental Compatibility Problem; Detachment of Device or Device Component; Environmental Compatibility Problem

  IT WAS REPORTED THAT DURING AN EMBOLIZATION OF AN ICA SUPRACLINOID RUPTURED ANEURYSM, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING AN EMBOLIZATION COIL IN THE MICROCATHETER. THE COIL WAS UNABLE TO ADVANCE, AND IT WAS REMOVED FROM THE PATIENT. DURING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE IMPLANT COIL HAD DETACHED INSIDE OF THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871926 ↗