HydroSoft Helical 100310H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777022943), received between Jun 26, 2024 and Apr 30, 2025 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  AS REPORTED: M2 BIFURCATION ANEURYSM WITH STENT AND COIL IMPLANTATION. THE OBJECTIVE OF THE PROCEDURE WAS TO RECROSS THE STENT AND IMPLANT MORE COILS. DR. SUCCESSFULLY RECROSSED THE STENT WITH A STRAIGHT MICROCATHETER. HE THEN ORDERED THE COIL. THE COIL PACKAGE WAS OPENED AND ITS CONTENTS PLACED ON THE TABLE. THE DISPENSER CAP WAS REMOVED AND THE COIL WAS REMOVED. ITS DISTAL END WAS HANDED TO THE DOCTOR, AND THE SPECIALIST HELD THE PROXIMAL END. THE DOCTOR OPENED THE HEMOSTATIC VALVE, INSERTED THE DISTAL END OF THE SHEATH, AND CLOSED THE VALVE AGAIN. SALINE RETURN THROUGH THE SHEATH WAS CONFIRMED, AND THE COIL WAS ADVANCED UNTIL THE PROXIMAL END WAS APPROXIMATELY ONE INCH OUTSIDE THE SHEATH. THE SHEATH WAS WITHDRAWN, AND THE DOCTOR CONTINUED ADVANCING THE DEVICE TO THE FLUOROSAFE MARKERS. ONCE UNDER FLUOROSCOPY, THE DOCTOR ADVANCED THE DEVICE AND OBSERVED THAT THE DISTAL END OF THE COIL WAS EXITING THE MICROCATHETER. HOWEVER, WHEN HE ATTEMPTED TO RETRIEVE THE DEVICE FOR BETTER POSITIONING, HE NOTICED RESISTANCE. HE ATTEMPTED TO ADVANCE AND RETRIEVE IT AGAIN WITHOUT SUCCESS. AT THAT POINT, THE DOCTOR NOTICED THAT THE STRETCH-RESISTANT ELEMENT OF THE DEVICE HAD BROKEN, SO HE DECIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932424 ↗
• InjuryJun 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COILING OF AN ANEURYSM, THE ANEURYSM WAS TREATED WITH 3D COILS. WHEN THE PHYSICIAN HAD ANOTHER COIL PASSED TO HIM, THE ASSISTANT ACCIDENTALLY PASSED A HELICAL COIL AND NOT A 3D COIL. THIS HELICAL COIL 3/10MM WAS ALSO PLACED IN THE ANEURYSM. THE PHYSICIAN THEN DECIDED TO TAKE THE HELICAL COIL OUT. WHILE TRYING TO RETRIEVE THE COIL, THE COIL DETACHED ITSELF. THE DETACHED COIL WAS EASILY RETRIEVED WITH A CATCH MINI RETRIEVAL DEVICE AND ECHELON CATHETER. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620276 ↗