HydroFrame 10 Advanced 101036HFRM-V-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425027219), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 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.

• InjuryApr 23, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT TWO FRAMING COILS WERE PLACED IN A BASILAR TIP ANEURYSM. THE HYDROFRAME COIL WAS THEN POSITIONED IN THE ANEURYSM; HOWEVER, PRIOR TO DETACHMENT, THE COIL WAS NOTED TO HAVE DETACHED INSIDE THE MICROCATHETER. UPON REMOVAL OF THE MICROCATHETER, THE IMPLANT COIL WAS NOTED TO BE PARTIALLY IN THE VESSEL AND PARTIALLY IN THE ANEURYSM. ATTEMPTS WERE MADE OVER APPROXIMATELY TWO HOURS TO REMOVE THE COIL WITH A SNARE DEVICE; HOWEVER, THE COIL SEGMENT BROKE IN TWO. THE COIL SEGMENT THAT EXTENDED INTO THE PARENT VESSEL WAS REMOVED WITH THE SNARE DEVICE AND THE DISTAL SEGMENT OF THE COIL REMAINED IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE OKAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453242 ↗