HydroSoft HelicalRecalls & reported problems across all models

We found 21 models of HydroSoft Helical by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2016 and May 28, 2026 — classified as 9 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 HydroSoft Helical problems

HydroSoft Helical models

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

• HydroSoft Helical 100154H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• HydroSoft Helical 100206H2HS-V-A2

  Device, Vascular, for Promoting Embolization
  3 reports
• HydroSoft Helical 100410H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• HydroSoft Helical 100520H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• HydroSoft Helical 100206H2HS-V-N

  Device, Vascular, for Promoting Embolization
  2 reports
• HydroSoft Helical 100208H2HS-V-N

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• HydroSoft Helical 100620H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• HydroSoft Helical 100310H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• HydroSoft Helical 100515H2HS-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100520H2HS-V

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100308H2HS-V-N

  Device, Vascular, for Promoting Embolization
  1 report
• HydroSoft Helical 100152H2HS-V-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100154H2HS-V-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100304H2HS-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroSoft Helical 100152H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100208H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100254H2HS-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroSoft Helical 100256H2HS-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroSoft Helical 100308H2HS-V-A2

  Device, Vascular, for Promoting Embolization
  1 report
• HydroSoft Helical 100510H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• HydroSoft Helical 100515H2HS-V-A2

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent HydroSoft Helical adverse event reports

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

• MalfunctionMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE EMBOLIZATION COIL IMPLANT WAS INTRODUCED INTO THE MICROCATHETER AND POSITIONED WITHIN THE ANEURYSM, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE DETACHMENT DEVICE. AT THAT POINT, IT BECAME APPARENT THAT THE PROXIMAL END OF THE DELIVERY PUSHER DESIGNED TO BE INSERTED INTO THE DETACHMENT DEVICE WAS MISSING. AS A RESULT, THE COIL HAD TO BE WITHDRAWN FROM THE ANEURYSM BACK INTO THE MICROCATHETER AND SUBSEQUENTLY REMOVED COMPLETELY FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH THE NEW COIL. THE BROKEN OR MISSING PART OF THE PUSHER WAS OUTSIDE OF THE PATIENT'S BODY. THE WAS NO PATIENT INJURY AND THEIR CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323333 ↗
• MalfunctionFeb 6, 2026Premature Separation

  AS REPORTED: DR. WAS TREATING A RUPTURED PICA ANEURYSM ON THE RIGHT. A COIL EMBOLIZATION WAS PLANNED AS THE TREATMENT. AFTER PLACING SEVERAL MV COILS, A HYDROSOFT 3-4 WAS CHOSEN. THE COIL HAD TO BE REPOSITIONED IN THE ANEURYSM. WHEN DR. TRIED TO REMOVE THE COIL FROM THE ANEURYSM, IT PREMATURELY DETACHED. THERE WAS ONLY ONE LOOP REMAINING IN THE ANEURYSM. DR. WAS ABLE TO REMOVE THE COIL FROM THE ANEURYSM AND PATIENT BODY BY PULLING BACK THE MICROCATHETER. COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT BODY COMPLETELY. THE COIL WAS EXCHANGED TO A HYDROSOFT OF SAME SIZE AND THE EXAMINATION COMPLETED. THE PATIENT IS DOING WELL. NO INJURY CAUSED BY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283737 ↗
• MalfunctionSep 15, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT DURING A TREATMENT OF A RIGHT M2 MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, A JAILING TECHNIQUE WAS PERFORMED USING THE COMBINATION OF A STENT AND COIL. AFTER THE CATHETERIZING THE ANEURYSM AND INTRODUCING THE FIRST COIL LOOP, THE STENT WAS RELEASED. THEN, A MICROCATHETER WITH A PARTIALLY DEPLOYED COIL WAS ADVANCED TOWARD THE INFERIOR M2 BRANCH. ATTEMPTS TO REPOSITION AND RECAPTURE THE COIL WITHIN THE ANEURYSM WERE UNSUCCESSFUL. GIVEN THE LACK OF RESPONSE, THE PHYSICIAN PROCEEDED TO APPLY TRACTION ON THE PUSHER, BUT THE COIL DID NOT RETRACT. FINALLY, IT WAS CONFIRMED THAT THE STRETCHING AND RESISTANCE ON THE PART OF THE COIL CONNECTING AT ITS PRIMARY COIL HELIX HAD RUPTURED CAUSING IT TO BE UNDONE AND COMPLETELY ELONGATED. THE COIL WAS REMOVED FROM THE PATIENT AND WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY IMPLANTING A STENT. THERE WERE NO COMPLICATIONS. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058558 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE H11 FOR INVESTIGATION CONCLUSION.

  Patient problems: Stroke/CVA

  MAUDE report 22800873 ↗
• InjuryJun 11, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  PLEASE SEE SECTION H11 FOR INVESTIGATION RESULTS.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 22191342 ↗
• MalfunctionApr 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  AS REPORTED: M2 BIFURCATION ANEURYSM WITH STENT AND COIL IMPLANTATION. THE OBJECTIVE OF THE PROCEDURE WAS TO RECROSS THE STENT AND IMPLANT MORE COILS. DR. SUCCESSFULLY RECROSSED THE STENT WITH A STRAIGHT MICROCATHETER. HE THEN ORDERED THE COIL. THE COIL PACKAGE WAS OPENED AND ITS CONTENTS PLACED ON THE TABLE. THE DISPENSER CAP WAS REMOVED AND THE COIL WAS REMOVED. ITS DISTAL END WAS HANDED TO THE DOCTOR, AND THE SPECIALIST HELD THE PROXIMAL END. THE DOCTOR OPENED THE HEMOSTATIC VALVE, INSERTED THE DISTAL END OF THE SHEATH, AND CLOSED THE VALVE AGAIN. SALINE RETURN THROUGH THE SHEATH WAS CONFIRMED, AND THE COIL WAS ADVANCED UNTIL THE PROXIMAL END WAS APPROXIMATELY ONE INCH OUTSIDE THE SHEATH. THE SHEATH WAS WITHDRAWN, AND THE DOCTOR CONTINUED ADVANCING THE DEVICE TO THE FLUOROSAFE MARKERS. ONCE UNDER FLUOROSCOPY, THE DOCTOR ADVANCED THE DEVICE AND OBSERVED THAT THE DISTAL END OF THE COIL WAS EXITING THE MICROCATHETER. HOWEVER, WHEN HE ATTEMPTED TO RETRIEVE THE DEVICE FOR BETTER POSITIONING, HE NOTICED RESISTANCE. HE ATTEMPTED TO ADVANCE AND RETRIEVE IT AGAIN WITHOUT SUCCESS. AT THAT POINT, THE DOCTOR NOTICED THAT THE STRETCH-RESISTANT ELEMENT OF THE DEVICE HAD BROKEN, SO HE DECIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932424 ↗
• MalfunctionDec 13, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COILING OF AN A. MEDIA-ANEURYSM IT WAS NOT POSSIBLE TO PUSH THE COIL THROUGH THE MICROCATHETER AND THEN THE COIL TORN OFF IN THE MICROCATHETER. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922028 ↗
• InjuryJun 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COILING OF AN ANEURYSM, THE ANEURYSM WAS TREATED WITH 3D COILS. WHEN THE PHYSICIAN HAD ANOTHER COIL PASSED TO HIM, THE ASSISTANT ACCIDENTALLY PASSED A HELICAL COIL AND NOT A 3D COIL. THIS HELICAL COIL 3/10MM WAS ALSO PLACED IN THE ANEURYSM. THE PHYSICIAN THEN DECIDED TO TAKE THE HELICAL COIL OUT. WHILE TRYING TO RETRIEVE THE COIL, THE COIL DETACHED ITSELF. THE DETACHED COIL WAS EASILY RETRIEVED WITH A CATCH MINI RETRIEVAL DEVICE AND ECHELON CATHETER. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620276 ↗
• InjuryJan 26, 2024Break; Stretched; Premature Separation; Break; Stretched; Premature Separation

  PLEASE SEE H6 AND H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592372 ↗
• MalfunctionJan 25, 2024Premature Separation; Premature Separation

  NO ADDITIONAL INFORMATION OR DEVICE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584744 ↗
• MalfunctionDec 12, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT THE COIL WAS INSERTED INTO THE HEADWAY AND RESISTANCE WAS FELT. THE COIL WAS NOT ABLE COME OUT OF THE HEADWAY. THEREFORE, THE PHYSICIAN PULLED OUT THE COIL AND THE MICROCATHETER AND THE COIL WAS OBSERVED TO BE DAMAGED. THE COIL WAS REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313569 ↗
• MalfunctionJul 31, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A RUPTURED POSTERIOR COMMUNICATING (PCOM) ANEURYSM, THE MICROCATHETER WAS POSITIONED INSIDE THE ANEURYSM OVER A TRAXCESS WIRE. AFTER DEPLOYING A COUPLE OF COILS, RESISTANCE WAS FELT WHILE PUSHING THE HYDROSOFT COIL INSIDE THE MICROCATHETER, AND THE PHYSICIAN DECIDED TO RE-SHEATH THE COIL. AFTER PULLING BACK THE PUSHER WIRE INTO THE COIL INTRODUCER SHEATH, IT WAS OBSERVED THE COIL HAD DETACHED INSIDE THE MICROCATHETER AND ONLY THE PUSHER WIRE WAS RETRIEVED. A FEW RUNS REVEALED 90% ANEURYSM OCCLUSION, SO THE PHYSICIAN DECIDED TO WITHDRAW THE MICROCATHETER AND STOP THE PROCEDURE. THE PATIENT WAS SHIFTED TO THE ICU POST PROCEDURE AND LATER DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431292 ↗
• InjuryApr 4, 2023Separation Failure; Device Dislodged or Dislocated; Difficult or Delayed Separation; Premature Separation; Separation Failure; Device Dislodged or Dislocated; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT FOR AN RT P. COM ANEURYSM, THE COIL PREMATURELY DETACHED WITHIN THE CATHETER AFTER MULTIPLE FAILED ATTEMPTS WERE MADE TO DETACH IT. THE PHYSICIAN USED THE DELIVERY WIRE TO PUSH THE COIL INTO THE ANEURYSM, LEAVING A SMALL PROTRUDING LOOP AT THE ANEURYSM¿S NECK. THE DOCTOR DECIDED A STENT WAS NOT REQUIRED. THE COIL REMAINS IMPLANTED IN THE PATIENT. ASPIRIN 500MG IV WAS ADMINISTERED TO THE PATIENT. THE OPERATIVE REPORT WAS REQUESTED AND WAS REPORTED AS NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679069 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE TO TREAT A 8.5MMX4MM PCM ANEURYSM, THE EMBOLIZATION COIL WAS USED AS A FILLING COIL, BUT WHILE PUSHING THE COIL INSIDE THE ANEURYSM, THE COIL UNINTENTIONALLY GOT DETACHED INSIDE THE MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. A NEW SET OF COIL AND MICROCATHETER WERE USED TO SUCCESSFULLY COMPLETE THE CASE. POST PROCEDURE RUNS WERE NORMAL AND THERE WAS NO FILLING OF ANEURYSM. THE PATIENT WAS EXTUBATED AND SHIFTED TO ICU FOR FURTHER OBSERVATION. NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447092 ↗
• MalfunctionDec 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED THROUGH THE RAGE STUDY, A PATIENT WITH A HISTORY OF HYPERTENSION AND HYPOTHYROIDISM PRESENTED WITH A ONE DAY HISTORY OF HEADACHES AND CONFUSION. THE PATIENT WAS FOUND TO HAVE DIFFUSE SUBARACHNOID HEMORRHAGE WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM ON CTA. THE PATIENT UNDERWENT ENDOVASCULAR, BALLOON ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH EXCELLENT OBLITERATION OF ANEURYSM, CONSISTENT WITH RAYMOND ROY GRADE 1. THE PROCEDURE WAS COMPLICATED BY INTRAPROCEDURAL RUPTURE. REPORTEDLY, FOLLOWING INSERTION OF A HYDROFRAME 5MM X 10CM EMBOLIZATION COIL IMPLANT (SEE MDR 2032493-2021-00502) , THE COIL WAS NOTED TO BE PARTIALLY PROTRUDING THROUGH THE ANEURYSM WALL INTO THE SUBARACHNOID SPACE. A TRANSFORM BALLOON WAS INFLATED AND A SECOND COIL WAS RAPIDLY PLACED WITHOUT EVIDENCE OF EXTRAVASATION ON THE FOLLOWING INJECTION. THE LAST COIL IMPLANT PARTIALLY HERNIATED INTO THE ANTERIOR COMMUNICATING ARTERY, BUT WITHOUT EVIDENCE OF SURROUNDING THROMBOSIS OR FLOW LIMITATION. DYNA CT SHOWED EVIDENCE OF NEW HEMORRHAGE, HOWEVER, WITH MILD HYDROCEPHALUS NECESSITATING EVD INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015994 ↗

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