HydroSoft Helical 100154H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777022844), received between Apr 15, 2020 and Aug 13, 2025 — classified as 1 injury, 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 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.

• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H11 FOR INVESTIGATION CONCLUSION.

  Patient problems: Stroke/CVA

  MAUDE report 22800873 ↗
• MalfunctionDec 13, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COILING OF AN A. MEDIA-ANEURYSM IT WAS NOT POSSIBLE TO PUSH THE COIL THROUGH THE MICROCATHETER AND THEN THE COIL TORN OFF IN THE MICROCATHETER. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922028 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF A DACA ANEURYSM, AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE DURING ADVANCEMENT AND DETACHED WITHIN THE MICROCATHETER DURING RETRACTION. THE COIL THE WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007930 ↗
• MalfunctionMay 1, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AFTER UNPACKING THE DEVICE, THE ZEBRA MARKS AT THE PROXIMAL END OF THE PUSHER COIL WERE NOTED TO BE MISSING FROM THE DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018057 ↗
• InjuryApr 15, 2020Entrapment of Device; Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACEMENT OF AN EMBOLIZATION COIL IN AN INTERNAL CAROTID ARTERY ANEURYSM, THE COIL COULD NOT BE DETACHED DESPITE SEVERAL ATTEMPTS. DURING REMOVAL OF THE COIL, A PREVIOUSLY PLACED COIL WAS DISLODGED. A MICROCATHETER AND A STENT RETRIEVER WERE USED TO RETRIEVE THE DISLOCATED COIL FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9961777 ↗