HydroSoft 3D 7110-0204-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816777025388), received between Dec 8, 2017 and Jun 2, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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.

• 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 ↗
• InjuryOct 23, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL WAS ATTEMPTED TO BE IMPLANTED IN THE ANEURYSM SHOULDER. THE COIL MIGRATED INTO THE PCA WHERE IT REMAINS IN THE WRONG AREA. A STENT WAS IMPLANTED. THE CASE WAS COMPLETED. THE PATIENT WILL RECEIVE NO FURTHER TREATMENT. THE PATIENT STATUS WAS REPORTED AS NO PATIENT HARM. THE OPERATIVE REPORT WAS REQUESTED, BUT IT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519131 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE (B)(6) STUDY THAT THE SUBJECT WAS ADMITTED ON (B)(6) 2022 FOR AN ELECTIVE EMBOLIZATION RECANALIZATION PROCEDURE OF PREVIOUSLY TREATED RUPTURED LEFT INTERNAL CAROTID ARTERY TERMINUS ANEURYSM (ICA). EVENT START DATE: 06/OCT/2021 POST OPERATIVE DAYS: 89 DAYS AE OUTCOME : RESOLVED WITHOUT SEQUELAE. THE REPORTED EVENT WAS DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767962 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY: FOUR DAYS POST-OP, PATIENT EXPERIENCED INCREASED LETHARGY, PROMPTING CT SCAN WHICH SHOWED INCREASE IN HEMORRHAGE IN RIGHT FRONTAL LOBE. A REPEAT CT SEVERAL HOURS LATER WAS STABLE. PATIENT WAS INTUBATED FOR AIRWAY PROTECTION. NEUROLOGICAL EXAM CONTINUED TO DECLINE AND PATIENT WAS TAKEN FOR ANGIOGRAM, WHERE HE UNDERWENT BALLOON ANGIOPLASTY AND PLACEMENT OF A PIPELINE STENT. NO RESIDUAL ANEURYSM WAS FOUND DURING PROCEDURE. RECOVERY WAS COMPLICATED BY VASOSPASM. PATIENT'S EXAM IMPROVED AFTER VASOSPASM TREATMENTS AND HE WAS EXTUBATED APPROXIMATELY 1.5 WEEKS AFTER PATIENT EXPERIENCED INCREASED LETHARGY. PATIENT RETURNED TO POST-COILING NEUROLOGIC BASELINE TWO DAYS LATER. ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE. AN INDEPENDENT REVIEWER (CEA) DETERMINED THAT THE REPORTED EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO STUDY PROCEDURE.

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 19753162 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY, IT WAS REPORTED THAT DURING 18-MONTH DSA, A 2.7MM X 2.4MM RECURRENCE OF THE PREVIOUSLY COILED BASILAR APEX ANEURYSM WAS FOUND AND SUBJECT PATIENT ASYMPTOMATIC. INVESTIGATOR DECIDED TO RETREAT AS THE UNRUPTURED ANEURYSM, ALTHOUGH RELATIVELY SMALL, IS NEAR THE SIZE OF THE PRIOR RUPTURED ANEURYSM. THE SUBJECT PATIENT BROUGHT BACK FOR RECOILING ON (B)(6) 2024 AND RETREATMENT EVENT OUTCOME RESOLVED WITHOUT SEQUELAE. THE EVENT WAS DETERMINED TO BE DEFINITELY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 19342799 ↗
• InjuryMar 4, 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 POSSIBLY RELATED TO THE STUDY DEVICE. THE SUBJECT PRESENTED WITH A CHIEF COMPLAINT OF HEADACHE. COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) REVIEW SHOWED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM AND MILD OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT UNDERWENT DIAGNOSTIC CEREBRAL ANGIOGRAM AND SUCCESSFUL COIL EMBOLIZATION OF THEIR ANEURYSM. POST PROCEDURE, THE PATIENT HAD ENCEPHALOPATHY AND APHASIA. REPEAT HEAD CT( COMPUTERIZED TOMOGRAPHY) SHOWED INCREASED HYDROCEPHALUS FROM BASELINE MILD HYDROCEPHALUS. THE NEUROSURGEON WAS CONSULTED AND EVALUATED THE SUBJECT, WHO HAD SINCE RETURNED TO BASELINE WITH RESOLUTION OF ENCEPHALOPATHY AND APHASIA WITH HOLDING OF SEDATING AGENTS. AE OUTCOME : RESOLVED WITHOUT SEQUELAE.

  Patient problems: Hydrocephalus; Speech Disorder

  MAUDE report 18824207 ↗
• MalfunctionDec 8, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, APPROXIMATELY 3CM OF THE COIL UNEXPECTEDLY DETACHED. THE COIL WAS THEN ADVANCED AND IMPLANTED IN THE INTENDED AREA WITH A GUIDEWIRE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100010 ↗