HydroSoft 3D 7110-0206-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816777025395), received between Aug 31, 2018 and Feb 9, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 28, 2024Component Missing; Migration; Component Missing; Migration

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE WARNING MARKERS WERE SEEN PRIOR TO THE COIL ENTERING THE PATIENT. WARNING MARKERS WERE NOT MISSING. THE COIL REMAINS IMPLANTED IN THE WRONG AREA. THE PATIENT WILL RECEIVE NO FURTHER TREATMENT. THE PATIENT'S CONDITION WAS REPORTED AS NOT HARMED. THE OPERATIVE REPORT WAS REQUESTED, BUT IT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20329051 ↗
• InjuryNov 3, 2023Migration; Premature Separation; Migration; Premature Separation

  A USER MEDWATCH WAS RECEIVED (B)(4) ON NOV 16TH, 2023, CONTAINING ADDITIONAL INFORMATION ABOUT THIS PREVIOUSLY REPORTED COMPLAINT. THE ADDITIONAL INFORMATION STATED THAT A 46 YR. OLD FEMALE PRESENTED FOR AN ELECTIVE CEREBRAL ANEURYSM COILING. THE STENTING OF THE VESSEL WAS SUCCESSFUL. THERE WAS NO EVIDENCE OF ACUTE OCCLUSION, AND THE PATIENT SYMPTOMS ARE IMPROVING.

  Patient problems: Speech Disorder

  MAUDE report 18066901 ↗
• InjuryMay 16, 2019Difficult to Remove; Stretched; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Stretched; Detachment of Device or Device Component; Device-Device Incompatibility

  A MEDSUN REPORT # (B)(4) WAS RECEIVED AND REPORTED THAT A PATIENT WITH A RIGHT MEDIAL TEMPORAL INTRA-CRANIAL HEMORRHAGE WITH ASSOCIATED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM UNDERWENT DIAGNOSTIC FEMORAL CEREBRAL ANGIOGRAM WITH PRIMARY COIL EMBOLIZATION OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. FOUR (4) COILS WERE DEPLOYED. FOLLOWING THIS, A HYRDROSOFT 3D (2MM X 6CM) COIL WAS DEPLYED. PER THE OPERATIVE REPORT, INCREASED RESISTANCE WAS MET UPON DEPLOYMENT OF THIS COIL, AND UPON RESPOSITIONING THE COIL WITHIN THE ANEURYSM SAC, THE COIL WAS IDENTIFIED TO HAVE STRETCHED AND DETACHED ON ITS OWN. IN THE PROCESS TO ADJUST, IT WAS NOTED THE COIL TAIL HERNIATED INTO THE INTERNAL CAROTID ARTERY. THE COIL WAS EVENTUALLY SNARED AND REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT DATE WAS NOTED AT (B)(6) 2019; HOWEVER, THE EXACT DATE WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616696 ↗
• InjuryFeb 7, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN EMBOLIZATION COIL IN A PATIENT ENROLLED IN A CLINICAL TRIAL, A SMALL PORTION OF THE COIL (TAIL) EXTENDED INTO THE PARENT ARTERY. THE PATIENT WAS PRESCRIBED 325MG ASPIRIN DAILY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318969 ↗
• InjurySep 11, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN EMBOLIZATION COIL IN A RUPTURED INTERNAL CAROTID ARTERY ANEURYSM, THE PROXIMAL END OF THE COIL (TAIL) DID NOT STAY IN THE ANEURYSM AND EXTENDED INTO THE PARENT VESSEL. THERE WAS NO EVIDENCE OF THROMBUS FORMATION; HOWEVER, THE PATIENT HAS BEEN PRESCRIBED DAILY BABY ASPIRIN TO AVOID PLATELET AGGREGATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866304 ↗
• InjuryAug 31, 2018Migration; Migration

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS IMPLANTED IN A RUPTURED BASILAR APEX ANEURYSM ON (B)(6) 2018. APPROXIMATELY 13 DAYS LATER, A STRAIGHT, TAIL-LIKE SEGMENT OF THE COIL CAME OUT OF THE ANEURYSM INTO THE PROXIMAL RIGHT POSTERIOR CEREBRAL ARTERY. A CLOT WAS NOTED AROUND THE TAIL SEGMENT, AND A THALAMIC STROKE WAS OBSERVED. ASPIRIN AND HEPARIN WERE ADMINISTERED TO THE PATIENT AS TREATMENT FOR THE CLOT. A CEREBRAL ANGIOGRAPHY SHOWED NO EVIDENCE OF THROMBOEMBOLIC COMPLICATIONS. THE CLOT APPEARS TO HAVE RESOLVED AND THERE ARE NO STROKE SYMPTOMS. THE PATIENT IS REPORTED TO BE RECOVERING WELL.

  Patient problems: Thrombus

  MAUDE report 7840080 ↗