HydroFrame 10 Advanced 100408HFRM-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023513), received between Mar 27, 2018 and Apr 21, 2025 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE MICROCATHETER WAS DELIVERED TO THE BASE OF THE ANEURYSM, UPON DELIVERING THE COIL THE RESISTANCE WAS FELT (BEFORE REACHING THE 'ZEBRA' MARKER). WHILE THE COIL WAS BEING REMOVED, IT DETACHED AND GOT STUCK IN THE MICROCATHETER. ADDITIONAL INFORMATION: THE CLINIC INFORMED US THAT THE SITUATION HAD NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877967 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY, RAGE "THE REPORTED ANEURYSM RECANALIZED AND REQUIRED RETREATMENT THAT ALSO RESULTED IN A MALFUNCTION, THE MICROCATHETER DISPLACING. EVENT INFORMATION EVENT TERM: ANEURYSM RECANALIZATION EVENT #: 4 EVENT START DATE: (B)(6) 2019. POST OPERATIVE DAYS: 82 DAYS EVENT DESCRIPTION MRI (B)(6) 2019 RECANALIZED NECK MEASURING 7X6X4MM ENLARGED COMPARED TO PREVIOUS. DSA (B)(6) 2020 RETREATMENT OF ANEURYSM, AT THE END OF THE PROCEDURE MINIMAL ANEURYSM FILLING. MRI (B)(6) 2020 SMALL RESIDUAL AT NECK OF BASILAR TIP ANEURYSM, SIGNIFICANTLY DECREASED COMPARED TO MRI ON (B)(6) 2019. MRI (B)(6) 2021 MINIMALLY INCREASED CONTRAST OPACIFICATION NOTED AT NECK OF PREVIOUSLY COILED BASILAR TIP ANEURYSM. REASON #8 NOT DETACHED: MICROCATHETER DISPLACED SO COIL NOT DEPLOYED AE OUTCOME : RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 20413587 ↗
• MalfunctionAug 20, 2020Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF THE SECOND COIL IN AN ANEURYSM, THE PREVIOUSLY PLACED COIL WAS DISLOCATED AND STRETCHED, AND THE SECOND COIL COULD NOT ADVANCE INTO THE ANEURYSM. DURING THE ATTEMPT TO WITHDRAW THE SECOND COIL, THE COIL DETACHED IN THE MICROCATHETER. PART OF THE DETACHED COIL REMAINS IN THE ANEURYSM AND PART OF THE COIL IS IN THE PARENT VESSEL. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WOKE UP IMMEDIATELY AFTER THE PROCEDURE AND HAD NO ABNORMAL SYMPTOMS. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "NORMAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429313 ↗
• DeathMar 27, 2018Migration or Expulsion of Device; Difficult To Position; Migration or Expulsion of Device; Difficult To Position

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ACUTE ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE FRAMING COIL DID NOT FULLY ADVANCE INTO THE ANEURYSM, LEAVING APPROXIMATELY 1CM OF THE COIL IN THE A1 SEGMENT. COIL LOOPS HAD PERFORATED THE ANEURYSM; THEREFORE, AN ATTEMPT WAS MADE TO DETACH THE COIL. THE COIL DID NOT DETACH AFTER FOUR (4) ATTEMPTS WERE MADE. A BALLOON WAS INFLATED TO PROTECT THE ANEURYSM. AFTER AN ATTEMPT TO RESHEATH AND REMOVE THE COIL, THE COIL APPEARED TO MIGRATE INTO THE MIDDLE CEREBRAL M1 - M3 ARTERIAL SEGMENTS. ADDITIONAL COILS WERE THEN IMPLANTED IN THE ANEURYSM. PART OF THE 1ST COIL WAS REMOVED FROM THE MIDDLE CEREBRAL ARTERY. A CLOT WAS THEN NOTED IN THE MIDDLE CEREBRAL ARTERY, AND A STENT RETRIEVER WAS USED. THE PATIENT WAS REPORTED TO HAVE DIED; HOWEVER, IT IS UNKNOWN WHEN THE DEATH OCCURRED. THE CAUSE OF THE PATIENT'S DEATH IS ALSO UNKNOWN.

  Patient problems: Death; Rupture; Thrombus

  MAUDE report 7376187 ↗