HydroSoft 3DRecalls & reported problems across all models
Microvention, Inc. · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 101
- Deaths reported
- 1
- Injuries reported
- 52
- Recalls
- 0
We found 26 models of HydroSoft 3D by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Jun 16, 2017 and Sep 30, 2026 — classified as 1 death, 52 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (40 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
Reports received per month, all models
Most reported HydroSoft 3D problems
Device problems
- Detachment of Device or Device Component40
- Adverse Event Without Identified Device or Use Problem17
- Premature Separation17
- Stretched14
- Separation Failure10
- Unraveled Material9
- Difficult to Remove8
- Device-Device Incompatibility6
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient25
- Aneurysm7
- Insufficient Information2
- Neurological Deficit/Dysfunction2
- No Known Impact Or Consequence To Patient2
- Ruptured Aneurysm2
- Speech Disorder2
HydroSoft 3D models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HydroSoft 3D 7110-0308-3D-A2Device, Vascular, for Promoting Embolization9 reports
- HydroSoft 3D 100310HFRM-V-3D-A2Device, Vascular, for Promoting Embolization8 reports
- HydroSoft 3D 7110-0204-3D-A2Device, Vascular, for Promoting Embolization7 reports
- HydroSoft 3D 7110-0206-3D-A2Device, Vascular, for Promoting Embolization7 reports
- HydroSoft 3D 7110-0310-3D-A2Device, Vascular, for Promoting Embolization7 reports
- HydroSoft 3D 7110-0208-3D-A2Device, Vascular, for Promoting Embolization6 reports
- HydroSoft 3D 7110-0256-3D-A2Device, Vascular, for Promoting Embolization6 reports
- HydroSoft 3D 7110-0258-3D-A2Device, Vascular, for Promoting Embolization5 reports
- HydroSoft 3D 100206HFRM-V-3D-A2Device, Vascular, for Promoting Embolization5 reports
- HydroSoft 3D 100208HFRM-V-3D-A2Device, Vascular, for Promoting Embolization1 death5 reports
- HydroSoft 3D 7110-0203-3D-A2Device, Vascular, for Promoting Embolization4 reports
- HydroSoft 3D 100204HFRM-V-3D-A2Device, Vascular, for Promoting Embolization4 reports
- HydroSoft 3D 100308HFRM-V-3D-A2Device, Vascular, for Promoting Embolization4 reports
- HydroSoft 3D 7110-0102-3D-A2Device, Vascular, for Promoting Embolization3 reports
- HydroSoft 3D 7110-0304-3D-A2Device, Vascular, for Promoting Embolization3 reports
- HydroSoft 3D 100154HFRM-V-3D-A2Device, Vascular, for Promoting Embolization3 reports
- HydroSoft 3D 7110-0154-3D-A2Device, Vascular, for Promoting Embolization2 reports
- HydroSoft 3D 100102HFRM-V-3D-A2Device, Vascular, for Promoting Embolization2 reports
- HydroSoft 3D 100254HFRM-V-3D-A2DEVICE, NEUROVASCULAR EMBOLIZATION2 reports
- HydroSoft 3D 100256HFRM-V-3D-A2Device, Vascular, for Promoting Embolization2 reports
- HydroSoft 3D 100306HFRM-V-3D-A2Device, Vascular, for Promoting Embolization2 reports
- HydroSoft 3D 7110-0152-3D-A2Device, Vascular, for Promoting Embolization1 report
- HydroSoft 3D 7110-0153-3D-A2Device, Vascular, for Promoting Embolization1 report
- HydroSoft 3D 100103HFRM-V-3D-A2Device, Vascular, for Promoting Embolization1 report
- HydroSoft 3D 100152HFRM-V-3D-A2Device, Vascular, for Promoting Embolization1 report
- HydroSoft 3D 100203HFRM-V-3D-A2Device, Vascular, for Promoting Embolization1 report
Recent HydroSoft 3D adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953606 ↗MalfunctionApr 29, 2026Premature Separation
AS REPORTED: ON APRIL 1, 2026, IN INTERVENTIONAL NEURORADIOLOGY, THE COIL DEPLOYED WITHIN THE MICROCATHETER. THE COIL DETACHED INTO THE LUMEN OF THE MICROCATHETER. CASE WAS COMPLETED BY USING ANOTHER COIL. THE ENTIRE SYSTEM WAS WITHDRAWN, AND THE SECOND COIL WAS SUCCESSFULLY USED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE INCIDENT WAS ISOLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25037696 ↗InjuryMar 31, 2026Malposition of Device
IT WAS REPORTED THAT THE PHYSICIAN SELECTED THE ANEURYSM WITH A HEADWAY 17 AND .014 GUIDEWIRE. AFTER HE ADVANCED THE COIL IN THE ANEURYSM HE DETACHED, AND THE COIL GOT STUCK IN THE CATHETER AS HE WAS PULLING BACK THE HEADWAY 17. PART OF THE COIL STAYED IN THE ANEURYSM AND PART OF THE COIL REMAINED IN THE PARENT VESSEL. THE COIL DID NOT EXTEND VERY FAR INTO THE VESSEL, SO THE PHYSICIAN DECIDED TO LEAVE THE COIL ALONE AND PUT THE PATIENT ON DAP THERAPY. THE OUTCOME WAS THAT THE PATIENT DID WELL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749098 ↗MalfunctionFeb 9, 2026Premature Separation
IT WAS REPORTED THAT THE COIL BROKE WHILE BEING DEPLOYED THROUGH AN ATLAS STENT. ANOTHER STENT WAS NEEDED TO TACK THE COIL UP AND KEEP IT OUT OF THE PARENT VESSEL. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300304 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FOR A PATIENT ENROLLED IN THE CAR REGISTRY STUDY FOR A RUPTURED ANEURYSM TREATMENT OF ANTERIOR COMMUNICATING ARTERY THAT THE PATIENT EXPERIENCES INTERMITTENT DIPLOPIA, ESPECIALLY WHEN TIRED. EVENT ONSET DATE: AUGUST 31, 2025 . AE RELATEDNESS: RELATIONSHIP TO STUDY DEVICE: POSSIBLY RELATED . RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLY RELATED. RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED. RELATIONSHIP TO STUDY DISEASE: PROBABLY RELATED. RELATIONSHIP TO CONCURRENT DISEASE: NOT RELATED. RELATIONSHIP TO DUAL ANTIPLATELET THERAPY: NOT RELATED. POST OPERATIVE DAYS: 39 WAS THE AE CAUSED BY OR ASSOCIATED WITH A DEVICE DEFICIENCY? NO OUTCOME: RESOLVED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT REPORTING DIFFICULTY REMEMBERING NEW INFORMATION. EVENT ONSET DATE: AUGUST 31, 2025 . AE RELATEDNESS: RELATIONSHIP TO STUDY DEVICE: POSSIBLY RELATED, RELATIONSHIP TO INDEX ENDOVASCULAR PROCEDURE: POSSIBLY RELATED, RELATIONSHIP TO USE OF ANCILLARY DEVICE: NOT RELATED, RELATIONSHIP TO STUDY DISEASE: POSSIBLY RELATED, RELATIONSHIP TO CONCURRENT DISEASE: POSSIBLY RELATED, RELATIONSHIP TO DUAL ANTIPLATELET THERAPY: NOT RELATED. POST OPERATIVE DAYS: 39 WAS THE AE CA
Patient problems: Diplopia/Double Vision; Memory Loss/Impairment
MAUDE report 24218183 ↗InjuryDec 16, 2025Break; Unraveled Material; Break; Unraveled Material
AS REPORTED THROUGH MEDSUN REPORT RECEIVED REF. # (B)(4), WHILE PLACING A COIL WITHIN A STENT TO TREAT A CEREBRAL ANEURYSM, THE COIL BECAME CAUGHT ON THE STENT AND BROKE THE STENT AND THE COIL UNRAVELED. A FIBER FROM THE COIL WAS UNABLE TO BE RETRIEVED AND IS STILL IN THE PATIENT'S ARTERY. THERE IS NO TREATMENT FOR THIS ISSUE, AND THIS SHOULD NOT CAUSE ANY HARM TO THE PATIENT. THE ANEURYSM WAS SUCCESSFULLY STENTED. ORIGINAL INTENDED PROCEDURE: CEREBRAL ANEURYSM COILING. ADDITIONAL INFORMATION INDICATED: THERE IS NO PRODUCT SAMPLE AVAILABLE FOR RETURN EVALUATION WAS IT WAS DISCARDED. NO FURTHER TREATMENT IS PLANNED. THE PATIENT WILL LIKELY HAVE A 6-MONTH FOLLOW-UP. THE PATIENT WAS MONITORED AND REPORTED TO BE DOING WELL ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824569 ↗MalfunctionDec 15, 2025Device Dislodged or Dislocated; Therapeutic or Diagnostic Output Failure
PATIENT CAME TO OPERATING ROOM FOR ENDOVASCULAR PROCEDURE WITH STENT. WHILE DEPLOYING STENT THROUGH DEPLOYMENT SYSTEM, SYSTEM PARTIALLY FAILS AND TIP OF DEPLOYMENT SYSTEM BECOMES DISLODGED. TIP IS RETRIEVED FROM INSIDE PATIENT, NO FOREIGN BODY LEFT IN PATIENT. STENT IS AN ABBOTT SUPERA PERIPHERAL STENT SYSTEM.
Patient problems: Insufficient Information
MAUDE report 23802268 ↗InjuryNov 12, 2025Premature Separation; Premature Separation
IT WAS REPORTED THE PHYSICIAN WAS PERFORMING AN L ACOMM EMBOLIZATION CASE. TN COILS#1-10 WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUE WITH HEADWAY DUO#1. THE PHYSICIAN INSERTED AN ARISTOTLE 14 GUIDEWIRE, AFTER USING THE GUIDEWIRE SEVERAL TIMES TO RE-POSITION DURING THE CASE, WITH HEADWAY DUO#1 AFTER COIL#10 WAS DEPLOYED TO RE-POSITION ONCE AGAIN. THE ARISTOTLE 14 WOULD NOT ADVANCE INTO THE HEADWAY DUO#1 (B)(4). THE ARISTOTLE 14 WAS REMOVED, AND A SYNCHRO SOFT GUIDEWIRE WAS USED WITHOUT ISSUE TO RE-POSITION. PROCEDURE CONTINUED AND THEN COIL#11 WHICH WOULD NOT ADVANCE INTO THE HUB OF THE HEADWAY DUO #1, TN COIL#11 WAS SET ASIDE AND A NEW HEADWAY DUO#2 WAS OPENED AND CASE CONTINUED WITH COIL#11 BEING INSERTED WITHOUT ISSUE. TN COIL#12 WAS INSERTED INTO HEADWAY DUO#2 AND WOULD NOT ADVANCE. COIL#12 WAS SET ASIDE, AND A NEW COIL WAS CHOSEN. TN COIL#13 WOULD ALSO NOT ADVANCE INTO HEADWAY DUO#2. BOTH HEADWAY DUO#2 AND COIL#13 WERE SET ASIDE FOR RETURN. HEADWAY DUO#3 WAS OPENED AND TN COIL#14 AND #15 INSERTED WITHOUT ISSUE. TN COIL#16 WOULD NOT ADVANCE IN HEADWAY DUO#3 (B)(4). TN COIL#17 OPENED AND DEPLOYED WITHOUT ISSUE. TN COIL#18 ADVANCED INTO HEADWAY DUO#3 WITHOUT ISSUE BUT WOULD NOT FULLY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539137 ↗MalfunctionOct 29, 2025Premature Separation; Premature Separation
NO ADDITIONAL INCIDENT INFORMATION WAS RECEIVED. HOWEVER, IT WAS REPORTED THAT THE HOSPITAL DID NOT SAVE THE COIL AND MICROCATHETER AND WAS ONLY PROVIDED THE COIL PUSHER BODYCOIL. PLEASE SEE H6 & H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411684 ↗InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: PATIENT WAS ADMITTED FOR EVALUATION OF SUDDEN ONSET OF DIZZINESS AND NAUSEA/VOMITING. PER CHART REVIEW, PATIENT PRESENTED TO THE ER FOR EVALUATION OF THESE SYMPTOMS ALONG WITH GENERALIZED WEAKNESS. PATIENT STATED THAT HER DIZZINESS WORSENED WITH POSITION CHANGES AND STATED THE ROOM FELT LIKE IT WAS SPINNING. LABORATORY FINDINGS WERE RELATIVELY UNREMARKABLE. CHEST X-RAY ALONG WITH CT ABDOMEN/PELVIS DID NOT SHOW ANY ACUTE ETIOLOGIES FOR NAUSEA/VOMITING. A BRAIN MRI WAS OBTAINED THAT DEMONSTRATED AN UNRUPTURED 7 MM SACCULAR ANTERIOR COMMUNICATING ARTERY ANEURYSM. TWO DAYS AFTER ADMISSION, PATIENT UNDERWENT BALLOON ASSISTED COILING OF ACOM ANEURYSM. POST OP, PATIENT WAS ADMITTED TO THE ICU FOR CLOSE NEUROLOGICAL MONITORING/CONTINUATION OF CARES. TWO DAYS AFTER BALLOON ASSISTED COILING, PATIENT UNDERWENT STENT ASSISTED COILING GIVEN SMALL RESIDUAL ACOM ANEURYSM AT LOBULATED BASE.
Patient problems: Aneurysm
MAUDE report 22128815 ↗MalfunctionMar 4, 2025Component Missing; Component Missing
IT WAS ORIGINALLY REPORTED THE INTRODUCER FAILED TO DETECT THE INSERTION OF THE COIL INSIDE. THE COIL COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO COIL AT THE DISTAL PART OF THE PUSHER. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS IS GOOD; THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE. NO OTHER CLARIFICATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21521232 ↗MalfunctionFeb 6, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED DURING A COIL EMBOLIZATION PROCEDURE, THE SECOND TO THE LAST COIL WOULD NOT DETACH USING A DETACHMENT CONTROLLER. WHEN THE COIL WAS PULLED BACK, IT DETACHED INSIDE THE MICROCATHETER, AND THE COIL WAS PUSHED INTO THE ANEURYSM USING A GUIDEWIRE. ANOTHER COIL WAS PLACED IN THE ANEURYSM, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21327398 ↗InjuryJan 17, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INCIDENT INFORMATION WAS PROVIDED, DEVICE WAS DISCARDED. PLEASE SEE H6 & H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21186033 ↗InjuryJan 8, 2025Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component
MalfunctionDec 27, 2024Material Separation; Stretched; Premature Separation; Material Separation; Stretched; Premature Separation
AS REPORTED: MCA ANEURYSM TREATMENT, USUAL COIL USAGE STARTED. DURING PREPARATION OF COIL, THEY REALISED SOME WIRE DEBRIS ON THE HYPOTUBE. STARTED THE ACCESS INTO THE MICROCATHETER AND THE DEVICE WAS DETACHED FROM THE PUSHER. REMOVED ALL PARTS AND COLLECTED. PATIENT TREATED WITH OTHER COILS SUCCESSFULLY. PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028320 ↗
Other Microvention, Inc. products
- Azur CX Detachable22 models · 509 reports · 1 recall
- Stent63 models · 237 reports · 2 recalls
- Azur Detachable Helical HydroCoil42 models · 190 reports
- V-Trak75 models · 147 reports
- WEB14 models · 134 reports
- AZUR14 models · 104 reports
- MicroPlex Helical Soft9 models · 8 reports · 1 recall
- ERIC Retrieval Device3 models · 5 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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