HydroSoft 3D 100208HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777026521), received between Jul 17, 2020 and Mar 4, 2025 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Component Missing; Component Missing

  IT WAS ORIGINALLY REPORTED THE INTRODUCER FAILED TO DETECT THE INSERTION OF THE COIL INSIDE. THE COIL COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO COIL AT THE DISTAL PART OF THE PUSHER. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS IS GOOD; THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE. NO OTHER CLARIFICATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521232 ↗
• MalfunctionAug 3, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE DURING ADVANCEMENT IN A MICROCATHETER. THE COIL BECAME STUCK AND WAS REMOVED. DURING REMOVAL, THE IMPLANT DETACHED FROM THE PUSHER. THE COIL WAS REPLACED AN THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER COIL. THERE WAS NO PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455834 ↗
• InjuryMar 12, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF ANEURYSM, THE COIL WAS POSITIONED FOR DESIRABLE PLACEMENT. THE COIL BECAME STUCK WITHIN THE MICROCATHETER, STRETCHED AND COULD NOT BE WITHDRAWN. THE COIL WAS REMOVED USING A SNARE DEVICE SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13745385 ↗
• DeathJun 18, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT MV COILS WERE UTILIZED TO TREAT A SERIOUSLY ILL PATIENT WITH A RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY. AFTER SUCCESSFUL PLACEMENT OF FOUR COILS, THE SURGEON REPORTED DIFFICULTY IN REPOSITIONING OF THE 5TH EMBOLIZATION COIL. THE COIL APPARENTLY DETACHED DURING REPOSITIONING, COULD NOT BE REMOVED, AND APPROXIMATELY 4CM OF THE COIL WAS LEFT IN THE ICA AND A1 SEGMENT OF THE ACA. A STENT WAS PLACED TO AFFIX THE COIL TO THE WALLS OF THE VESSEL. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY THE FOLLOWING DAY AS A RESULT OF A RE-BLEED OF THE ANEURYSM. THE NEUROSURGERY TEAM CONSIDERED THE SURGERY EXTREMELY HIGH RISK GIVEN THE PATIENT'S PRE-PROCEDURE CONDITION, AND REPORTED THAT THE DEATH WAS NOT DUE TO THE CHALLENGES ENCOUNTERED IN THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 12029245 ↗
• MalfunctionJul 17, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED AFTER PLACEMENT OF AN EMBOLIZATION COIL IN AN ANEURYSM, THE COIL COULD NOT BE DETACHED WITH THE CONTROLLER. DURING REMOVAL, THE COIL DETACHED FROM THE PUSHER WIRE. BOTH SEGMENTS OF THE COIL WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292584 ↗