HydroFrame 10 Advanced 100728HFRM-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023575), received between Jun 12, 2018 and Dec 9, 2024 — classified as 1 death, 2 injuries, 1 malfunction.

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 16, 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.

• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH "RAGE CLINICAL STUDY" PARTICIPANT UNDERWENT STANDARD MRA. PER IMAGING, FINDINGS WERE CONSISTENT WITH RESIDUAL FILLING OF THE BASE OF THE PREVIOUSLY COILED LARGE BASILAR TIP ANEURYSM. PATIENT UNDERWENT RETREATMENT FOR (PULSE RIDER T-STENT). THE PARTICIPANT REMAINED IN THE HOSPITAL FOR OBSERVATION FOR ONE DAY AND WAS DISCHARGED. PARTICIPANT WAS INSTRUCTED TO CONTINUE ASPIRIN 81 MG DAILY FOR LIFE AND PLAVIX 75 MG DAILY FOR 3 MONTHS POST-PROCEDURE. INVESTIGATOR DETERMINED RESULT AS RAYMOND ROY CLASS II. AE OUTCOME: RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 20884174 ↗
• InjuryMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF ANEURYSM, THE COIL WAS POSITIONED FOR DESIRABLE PLACEMENT. THE COIL BECAME STUCK WITHIN THE MICROCATHETER, STRETCHED AND COULD NOT BE WITHDRAWN. AFTER SEVERAL ATTEMPTS, THE COIL SEPARATED FROM THE DELIVERY PUSHER. THE COIL WAS REMOVED USING A SNARE DEVICE SUCCESSFULLY. NO HARM OR INJURY TO THE PATIENT, WHO WAS REPORTED TO BE DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861137 ↗
• DeathApr 16, 2021Difficult or Delayed Positioning; Difficult to Remove; Stretched; Difficult or Delayed Positioning; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY, AN EMBOLIZATION COIL STRETCHED AND DETACHED DURING AN ATTEMPT TO RE-FRAME IT. A PORTION OF THE IMPLANT COIL REMAINED IN THE PARENT VESSEL. A STENT WAS PLACED AT THE NECK OF THE ANEURYSM TO AFFIX THE STRETCHED COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONCERNS ABOUT BLOOD FLOW. THE PATIENT'S CONDITION WAS REPORTED TO HAVE DETERIORATED POST-PROCEDURE AND THE PATIENT PASSED AWAY LATER. THE OFFICIAL CAUSE OF DEATH WAS INTRACRANIAL HEMORRHAGE. IT WAS STATED BY THE TREATING PHYSICIAN THAT THE STRETCHED COIL DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11682815 ↗
• MalfunctionJun 12, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL IN THE MICROCATHETER. THE COIL WAS REMOVED AND CHECKED. A SECOND ATTEMPT WAS MADE TO ADVANCE THE COIL IN THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE COIL GOT STUCK. DURING REMOVAL, THE COIL DETACHED. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594610 ↗