HydroFrame 10 Advanced 100833HFRM-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023599), received between Feb 19, 2020 and Mar 20, 2025 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Unraveled Material; Separation Failure; Physical Resistance/Sticking; Unraveled Material; Separation Failure; Physical Resistance/Sticking

  AS REPORTED, THE COIL DID NOT DETACH. THE PHYSICIAN DECIDED TO REMOVE IT, ESPECIALLY SINCE ITS POSITIONING DID NOT REALLY SUIT HIM. DURING REMOVAL, THE COIL APPEARED AS STRETCHED: IT WAS IMPOSSIBLE TO PUSH OR PULL IT. BY USING SUCCESSIVELY A LASSO, A SOLITAIRE AND A BALLOON TO TRAP THE COIL, THE PHYSICIAN MANAGED TO REMOVE A LARGE PART OF THE STRETCHED COIL AND FINALLY DECIDED TO LEAVE THE REST IN THE ANEURYSM AND THE ARTERY. ADDITIONAL INFORMATION INDICATED: THE PHYSICIAN PUT AN ATLAS STENT: 3/24MM BEFORE THE FIRST HYDROFRAME COIL THAT HAS STRETCHED. THE COIL WAS THEN PUT THROUGH THE CELLS OF THE STENT. THE PATIENT CONDITION WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655846 ↗
• MalfunctionSep 12, 2024Premature Separation; Premature Separation

  AS REPORTED, DURING UNSPECIFIED ANEURYSM EMBOLIZATION PROCEDURE, THE COIL UNINTENTIONALLY DETACHED BEFORE REACHING THE ANEURYSM. REPORTEDLY, THE PATIENT IS FINE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206716 ↗
• MalfunctionOct 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT THE COIL ADVANCED 3-4CM IN THE MICROCATHETER AND WAS REPORTED TO HAVE BROKEN AND SEEN AND FELT TO HAVE RELEASED ITSELF FROM THE PUSHER THROUGH X-RAY. THE COIL WAS REMOVED SIMULTANEOUSLY THROUGH ASPIRATION ALONG WITH THE CATHETER WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629820 ↗
• MalfunctionFeb 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN EMBOLIZATION COIL, THE COIL PREMATURELY DETACHED AND GOT STUCK IN THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729408 ↗