HydroFill HelicalRecalls & reported problems across all models

We found 11 models of HydroFill Helical by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2016 and Aug 21, 2026 — classified as 10 injuries, 13 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 HydroFill Helical problems

HydroFill Helical models

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

• HydroFill Helical 100510HFIL-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• HydroFill Helical 100515HFIL-V-A2

  Device, Vascular, for Promoting Embolization
  4 reports
• HydroFill Helical 100620HFIL-V-A2

  Device, Vascular, for Promoting Embolization
  4 reports
• HydroFill Helical 100615HFIL-V-A2

  Device, Vascular, for Promoting Embolization
  3 reports
• HydroFill Helical 100206HFIL-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• HydroFill Helical 100720HFIL-V

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFill Helical 100204HFIL-V-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroFill Helical 101230HFIL-V-A

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFill Helical 100306HFIL-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroFill Helical 100930HFIL-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroFill Helical 100720HFIL-V-A2

  Device, Vascular, for Promoting Embolization
  1 report

Recent HydroFill Helical adverse event reports

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

• InjuryAug 21, 2026Unraveled Material; Migration; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50381055 ↗
• MalfunctionJun 30, 2025Premature Separation; Premature Separation

  AS REPORTED: THE HYDROFILL 6/20 COIL BROKE IN THE MICROCATHETER DURING THE COIL'S ASCENT TO THE ANEURYSM, IN A PATIENT ADMITTED FOR SAH AFTER ANEURYSM RUPTURE. THE DOCTOR REMOVED BOTH THE COIL AND MICROCATHETER. COIL WAS STUCK IN THE MICROCATHETER. NO SNARE WAS USED. NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355900 ↗
• MalfunctionApr 22, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ANEURYSM ON THE RIGHT MEDIA BIFURCATION. SHE WANTED TO COIL THE ANEURYSM USING A REMODELING TECHNIQUE. AFTER PLACING SEVERAL COILS, A HYDROFILL WAS CHOSEN. WHILE REPOSITIONING THE COIL PREMATURELY DETACHED. THE COIL WAS EXCHANGED AND THE EXAMINATION CONTINUED. AFTER SUCCESSFUL COILING THE IMPLANTATION OF A STENT WAS PLANNED AND CHOSEN. THE STENT PREMATURELY DETACHED IN THE MICROCATHETER. THE STENT WAS EXCHANGED AND THE EXAMINATION CONTINUED WITH GOOD RESULT. THE PATIENT IS DOING WELL. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887227 ↗
• MalfunctionNov 15, 2024Premature Separation; Premature Separation

  AS REPORTED: COILING OF M1 ANEURYSM. ATTEMPTED TO ADVANCE HYDROFILL COIL THROUGH A MICROCATHETER. WHILE ADVANCING THE COIL, IT PREMATURELY DETACHED ¿ PART IN CATHETER/PART IN THE ANEURYSM. THERE WAS ENOUGH COIL STILL IN THE MICROCATHETER, THAT WHEN THE DR PULLED THE CATHETER OUT, THE COIL CAME WITH IT. PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700853 ↗
• MalfunctionOct 3, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN SELECTED A 100515HFIL-V DURING A COILING. UPON ADVANCEMENT OF THE 100515HFIL-V THROUGH AN SL-10, THE COIL DETACHED ITSELF AROUND HALFWAY THOUGH THE MICROCATHETER. THE MICROCATHETER AND COIL WERE REMOVED. THE PATIENT IS REPORTED STABLE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364355 ↗
• MalfunctionSep 13, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND THEN DETACHED UNEXPECTEDLY. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE AND WELL." ANOTHER EMBOLIZATION COIL IMPLANT ENCOUNTERED THE SAME ISSUE DURING THE CASE AND WAS REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT 2032493-2024-00679.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218178 ↗
• MalfunctionSep 12, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND THEN DETACHED UNEXPECTEDLY. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE AND WELL." ANOTHER EMBOLIZATION COIL IMPLANT ENCOUNTERED THE SAME ISSUE DURING THE CASE AND WAS REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207961 ↗
• InjuryMay 8, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN PUT THE COÏL IN ANEURYSM (ACA). IT WAS THE SECOND COÏL. THE PHYSICIAN DECIDED TO REPOSITION THIS COÏL AFTER COMPLETE DEPLOYMENT. WHEN IT WAS RETRIEVED, THE COÏL BROKE AND AFTER SEVERAL ATTEMPTS TO RETRIEVE ALL OF THE COÏL, A HALF PART OF COÏL WAS LEFT IN THE VESSEL, CAROTID ARTERY. THE PHYSICIAN WAS THEN OBLIGED TO PUT TWO CAROTID STENTS INSIDE THE VESSEL TO MAINTAIN THE BROKEN COÏL. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT, "WHEN THE COIL WAS DETACHED USING THE DETACHMENT SYSTEM, THE SECTION WAS COMPLETED, BUT THE PUSHER CATHETER REMAINED ATTACHED. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE COIL AND PUSHER WITH RETRIEVER STENTS, IT ONLY ¿DESCENDED¿ TO THE LEVEL OF THE COMMON CAROTID ARTERY. IT WAS NECESSARY TO STENT THE CAROTID ARTERY WITH 2 CAROTID STENTS IN ORDER TO PLATE THE PUSHER AND STENT ALONG THE CAROTID WALL."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274207 ↗
• InjuryMar 13, 2023Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534995 ↗
• MalfunctionAug 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL JAILING PROCEDURE TO TREAT A BASILAR ANEURYSM, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER WHEN IT WAS APPROACHING THE ANEURYSM. THE FLOW DIVERTER WAS RECAPTURED AND THE ENTIRE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT. NO PATIENT INJURY OR INTERVENTION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154363 ↗
• MalfunctionJun 29, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED TO TREAT A PATIENT WITH A PRE-RUPTURED ANEURYSM. AFTER POSITIONING A MICROCATHETER INTO THE ANEURYSM SACK, THE PHYSICIAN STARTED DEPLOYING COILS. A FRAMING COIL WAS FIRST PLACED FOLLOWED BY THE HYDROFILL COIL THAT ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER. DURING ATTEMPT TO PULL BACK, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. CONSEQUENTLY, THE RUPTURED ANEURYSM WAS TREATED. REPORTEDLY, THE PATIENT WAS LEFT WITH SOME NON-SPECIFIED DEFICITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853380 ↗
• MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A PCOM ANEURYSM, THE IMPLANT COIL DETACHED UNEXPECTEDLY. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THE CASE WAS SUCCESSFULLY COMPLETED WITH OTHER COILS. THERE WAS NO REPORTED INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14256417 ↗
• InjuryApr 13, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A RUPTURED GIANT ACOM ANEURYSM (12MM), THE SECOND COIL WAS A HYDROFILL 9X30. THE COIL WAS PUSHED THROUGH A PROWLER 14 MICROCATHETER. APPROXIMATELY 50% OF THE COIL WAS INSIDE THE ANEURYSM AND RESISTANCE WAS ENCOUNTERED. IT WAS DECIDED TO WITHDRAW THE COIL. DURING THE WITHDRAW MANEUVER, THE COIL DETACHED FROM THE DELIVERY PUSHER PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED USING A SNARE OVER THE TRANSFEMORAL SHEATH. ADDITIONAL COILS WERE PLACE WITH GOOD RESULT. THE PATIENT WAS REPORTED TO BE INTUBATED ON ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14094804 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE EMBOLIZATION COIL DETACHED IN THE MICROCATHETER DURING POSITIONING. NO HARM TO PATIENT OR SECONDARY INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508299 ↗
• InjuryJan 6, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING TREATMENT OF A RECURRENT ACOM ANEURYSM VIA STENT ASSISTED COILING, THE COIL DID NOT DETACH WITH MULTIPLE ATTEMPTS. IT WAS DECIDED TO TRY AND REMOVE THE COIL FROM THE ANEURYSM BY WITHDRAWING IT INTO THE HW DUO. AFTER WITHDRAWING APPROXIMATELY 2CM OF COIL INTO THE MICROCATHETER THE COIL BECAME JAMMED AND COULD NOT BE WITHDRAWN FURTHER. THE MICROCATHETER WAS THEN ATTEMPTED TO BE WITHDRAWN FROM THE SAC ALONG WITH THE COIL. UPON WITHDRAWAL OF THE MICROCATHETER THE COIL WAS ENTANGLED WITHIN THE COIL MASS AND WAS UNABLE TO BE CLEANLY REMOVED. RETRACTION OF THE COIL PUSHER RESULTED IN PARTIAL SEPARATION OF THE PUSHER AND APPEARED TO DELAMINATE THE COIL AND A SNARE WAS EVENTUALLY USED TO RETRIEVE AS MUCH OF THE COIL AS POSSIBLE. A SMALL REMAINING FILAMENT TAIL REMAINED FROM THE ANEURYSM TO THE CAVERNOUS SECTION OF THE LEFT ICA AND THIS WAS STABILIZED AND TRAPPED AGAINST THE WALL WITH PLACEMENT OF A STENT. THE PATIENT RECOVERED TO BE DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173709 ↗

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