HydroSoft Helical 100152H2HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777022837), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT DURING A TREATMENT OF A RIGHT M2 MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, A JAILING TECHNIQUE WAS PERFORMED USING THE COMBINATION OF A STENT AND COIL. AFTER THE CATHETERIZING THE ANEURYSM AND INTRODUCING THE FIRST COIL LOOP, THE STENT WAS RELEASED. THEN, A MICROCATHETER WITH A PARTIALLY DEPLOYED COIL WAS ADVANCED TOWARD THE INFERIOR M2 BRANCH. ATTEMPTS TO REPOSITION AND RECAPTURE THE COIL WITHIN THE ANEURYSM WERE UNSUCCESSFUL. GIVEN THE LACK OF RESPONSE, THE PHYSICIAN PROCEEDED TO APPLY TRACTION ON THE PUSHER, BUT THE COIL DID NOT RETRACT. FINALLY, IT WAS CONFIRMED THAT THE STRETCHING AND RESISTANCE ON THE PART OF THE COIL CONNECTING AT ITS PRIMARY COIL HELIX HAD RUPTURED CAUSING IT TO BE UNDONE AND COMPLETELY ELONGATED. THE COIL WAS REMOVED FROM THE PATIENT AND WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY IMPLANTING A STENT. THERE WERE NO COMPLICATIONS. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058558 ↗