HydroSoft 3D 100206HFRM-V-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777026514), received between Feb 6, 2020 and Dec 27, 2024 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Material Separation; Stretched; Premature Separation; Material Separation; Stretched; Premature Separation

  AS REPORTED: MCA ANEURYSM TREATMENT, USUAL COIL USAGE STARTED. DURING PREPARATION OF COIL, THEY REALISED SOME WIRE DEBRIS ON THE HYPOTUBE. STARTED THE ACCESS INTO THE MICROCATHETER AND THE DEVICE WAS DETACHED FROM THE PUSHER. REMOVED ALL PARTS AND COLLECTED. PATIENT TREATED WITH OTHER COILS SUCCESSFULLY. PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028320 ↗
• InjuryDec 6, 2024Unraveled Material; Unraveled Material

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860704 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS FOR TREATMENT OF AN ACUTELY RUPTURED A2 SEGMENT ANEURYSM. THE EMBOLIZATION COIL WAS BEING USED AS THE SECOND COIL WHEN IT UNINTENTIONALLY DETACHED FROM THE PUSHER WIRE. A BALLOON WAS THEN INTRODUCED AND INFLATED TO PREVENT COIL PROLAPSING INTO PARENT VESSEL AND THE DESCRIBED COIL WAS PUSHED INTO THE ANEURYSM. ONCE THE COIL WAS SUCCESSFULLY PLACED WITHIN THE ANEURYSM, THE OPERATOR PULLED THE PUSHER WIRE BACK BUT THE PROXIMAL END OF THE COIL ALSO PULLED BACK. THE DETACHMENT CONTROLLER WAS THEN ATTACHED AND THE COIL WAS DETACHED SUCCESSFULLY. A SMALL AMOUNT OF EXTRAVASATION/RUPTURE OF THE ANEURYSM WAS NOTED, WHICH WAS QUICKLY TREATED WITH FURTHER COILS BEING PLACED. PATIENT INITIALLY HAD RIGHT SIDED WEAKNESS IN UPPER AND LOWER LIMB AND REPORTEDLY REGAINED LIMB POWER OVER FOLLOWING DAYS.

  Patient problems: Muscle Weakness/Atrophy; Ruptured Aneurysm

  MAUDE report 13805520 ↗
• MalfunctionMar 19, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON-ASSISTED COILING WAS PERFORMED FOR AN MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. DURING PLACEMENT OF THE THIRD COIL, RESISTANCE WAS ENCOUNTERED AND DURING THE ATTEMPT TO REMOVE THE COIL, IT DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857954 ↗
• MalfunctionFeb 6, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT COIL EMBOLIZATION WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. WHILE ADVANCING THE THIRD COIL, RESISTANCE WAS ENCOUNTERED AND DURING WITHDRAWAL, THE COIL DETACHED INSIDE THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679408 ↗