HydroFrame 10 AdvancedRecalls & reported problems across all models

We found 22 models of HydroFrame 10 Advanced by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2017 and Nov 14, 2025 — classified as 2 deaths, 18 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HydroFrame 10 Advanced problems

HydroFrame 10 Advanced models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HydroFrame 10 Advanced 100408HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 death4 reports
• HydroFrame 10 Advanced 100728HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 death4 reports
• HydroFrame 10 Advanced 100833HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  4 reports
• HydroFrame 10 Advanced 7110-0410-A2

  Device, Vascular, for Promoting Embolization
  4 reports
• HydroFrame 10 Advanced 100612HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  3 reports
• HydroFrame 10 Advanced 100619HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  3 reports
• HydroFrame 10 Advanced 100931HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  2 reports
• HydroFrame 10 Advanced 100415HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  2 reports
• HydroFrame 10 Advanced 100520HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  2 reports
• HydroFrame 10 Advanced 100306HFRM-V-A

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100510HFRM-V-A

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100715HFRM-V-A

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 101036HFRM-V-A

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 7110-0515

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 7110-0931

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 7110-0728

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100510HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100515HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100515HFRM-V-A1

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100715HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 100817HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFrame 10 Advanced 101036HFRM-V-A2

  Device, Vascular, for Promoting Embolization
  1 report

Recent HydroFrame 10 Advanced adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Stretched; Premature Separation; Stretched; Premature Separation

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562782 ↗
• InjuryJul 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE COIL BROKE DURING INSERTION AND HAD TO BE RECOVERED FROM THE PATIENT. THEY HAD ALREADY PLACED SOME COILS INTO THE ANEURYSM. THE AFFECTED COIL COULD BE ADVANCED THROUGH THE MICROCATHETER WITHOUT ANY ISSUES AND WAS DEPLOYED INTO THE ANEURYSM FOR APPROXIMATELY THE FIRST 2 MILLIMETERS. AFTER THAT, THE MICROCATHETER WAS PUSHED OUT OF THE ANEURYSM, AND THE COIL COULD NO LONGER BE MANIPULATED VIA THE PUSHER WIRE. THE COIL APPEARS TO HAVE BROKEN INSIDE THE MICROCATHETER ¿ BY ADVANCING A GUIDEWIRE THROUGH THE MICROCATHETER, THE DISTAL PART BEYOND THE FRACTURE SITE WAS CLAMPED. THIS ALLOWED THE DETACHED COIL TO BE RETRIEVED FROM THE PATIENT. THE PATIENT IS DOING WELL ¿ THE RECOVERY CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568831 ↗
• 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 ↗
• 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 ↗
• InjuryDec 12, 2024Premature Separation; Premature Separation

  IT WAS ORIGINALLY REPORTED THAT: " WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE COIL IN THE ANEURYSM, HE NOTICED IT WAS ALREADY DETACHED. AS PER THE PHYSICIAN, THE COIL IS DEFECTIVE." ADDITIONAL INCIDENT INFORMATION WAS RECEIVED. AS PER THE PHYSICIAN, THE COIL WAS INSERTED INTO THE CATHETER AND ADVANCED INTO THE ANEURYSM. UPON PLACEMENT, THE PHYSICIAN IDENTIFIED AN ISSUE WITH THE COIL AND THEREFORE ATTEMPTED TO RETRIEVE IT. HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL, INDICATING THAT THE COIL WAS DETACHED FROM THE BEGINNING. CONSEQUENTLY, THE CATHETER AND COIL HAD TO BE REMOVED AND THE PLANNED PROCEDURE COULD NOT BE COMPLETED. THE PHYSICIAN ONLY DEPLOYED 10% OF THE COIL AND THEREFORE THE COIL WAS NOT COMPLETELY DETACHED WITHIN THE ANEURYSM. PATIENT WAS LATER ON ADMITTED FOR A FLOW DIVERTER PROCEDURE WITH A DIFFERENT PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918581 ↗
• 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 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  H10.

  Patient problems: Aneurysm

  MAUDE report 20660042 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY: MRA (APPROXIMATELY TWO WEEKS PRIOR TO THE EVENT DATE) SHOWED A RECURRENT ACOM ANEURYSM NECK FILLING MEASURING BETWEEN 3 AND 5 MM WITH COIL COMPACTION SUGGESTED. THE SUBJECT UNDERWENT RETREATMENT ON WITH THE PLACEMENT OF A STENT. THE INDEX PROCEDURE WAS PERFORMED FOUR MONTHS PRIOR TO THE EVENT DATE.

  Patient problems: Aneurysm

  MAUDE report 20605095 ↗
• 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 ↗
• 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 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY, RAGE: SUBJECT PRESENTED FOR ROUTINE FOLLOW UP ANGIOGRAM ON (B)(6) 2019. ANEURYSM RECURRENCE WAS DISCOVERED. ON (B)(6) 2019 COIL EMBOLIZATION WAS PERFORMED TO TREAT RECURRENCE. FOLLOW UP ANGIOGRAM ON (B)(6) 2019 WAS PERFORMED AND CONFIRMED ANEURYSM OCCLUSION WITH NO COMPLICATIONS. RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 20171449 ↗
• MalfunctionSep 6, 2024Premature Separation; Premature Separation

  THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164293 ↗
• InjuryAug 22, 2024Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED: IT WAS IDENTIFIED THAT WHEN A 5X15 HYDROFRAME COIL WAS PLACED, IT HAD APPARENTLY RELEASED WITHOUT HAVING BEEN COMPLETELY IMPLANTED, SINCE A LARGE PART OF THE DEVICE WAS STILL IN THE MICROCATHETER DURING A CEREBRAL ANEURYSM OCCLUSION PROCEDURE IN THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY. THE DOCTOR MANAGED TO EXTRACT IT USING HIS OWN TECHNIQUE AND UPON REMOVING IT, IT WAS EVIDENT THAT IT HAD LENGTHENED AND THIS PREVENTED ITS PROPER PLACEMENT. THE PROCEDURE ENDS WITHOUT AFFECTING THE PATIENT. PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043218 ↗
• MalfunctionAug 12, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING THE ATTEMPT TO OCCLUDE AN ARTERIAL FEEDER OF A GALENUM VEIN, RE-SHEATHING THE COIL THROUGH THE HEADWAY17 TO SWITCH TO ANOTHER ONE, THE PHYSICIAN FELT A FRICTION DURING THE END OF THE MANEUVER AND EVENTUALLY PULLED THE WHOLE PUSHERWIRE OUT OF THE MICROCATHETER LEAVING THE COIL UNINTENTIONALLY DETACHED INTO THE MICROCATHETER ITSELF. HE THEN PULLED THE MICROCATHETER OUT OF THE PATIENT AND CHANGE IT WITH A NEW ONE WITH NO CLINICAL SEQUELAE. THE PATIENT IS REPORTED STABLE, STILL HOSPITALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968620 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RAGE CLINICAL STUDY THAT THE FOLLOWING EVENT WAS REVIEWED BY INDEPENDENT REVIEWER AND WAS DETERMINED TO BE POSSIBLY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE: INTRA-VENTRICULAR HEMORRHAGE. FOUR DAYS POST-PROCEDURE, A REPEAT NON-CONTRAST HEAD CT DEMONSTRATED MORE HEMORRHAGE IN THE POSTERIOR FOSSA AND INTRAVENTRICULAR HEMORRHAGE. AFTER REVERSAL OF ANTICOAGULATION, THE PATIENT UNDERWENT PLACEMENT OF A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN. CEREBRAL ANGIOGRAPHY RESULTED IN COMPLETE OCCLUSION OF VERTEBROBASILAR JUNCTION ANEURYSM. THE OUTCOME WAS REPORTED TO BE "RESOLVED WITHOUT SEQUELAE."

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19767761 ↗

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