HydroSoft 3D 7110-0310-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816777025487), received between May 6, 2019 and Jan 29, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• 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 ↗
• 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 ↗
• MalfunctionDec 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION RECEIVED THAT PROVIDED AN IMAGE AND WAS REVIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887300 ↗
• InjuryJul 1, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THE PHYSICIAN WAS TREATING A BASILAR TIP ANEURYSM WITH Y STENT AND MULTIPLE COILS. INITIAL COILS INSERTED AND IMPLANTED WITHOUT ISSUE. THE 3X10 HYDROSOFT 3D COIL PARTIALLY DEPLOYED INTO ANEURYSM AND THE PHYSICIAN TRIED TO RE-SHEATH AND RE-DEPLOY, BUT THE COIL PREMATURELY DETACHED INSIDE THE CATHETER. THE COIL WAS SNARED AND REMOVED FROM THE PATIENT. THE PROCEDURE CONTINUED AND SUCCESSFULLY COMPLETED USING A FEW MORE COILS OF DIFFERENT BRAND. THERE WAS NO HARM OR INJURY TO THE PATIENT, WHO REPORTEDLY WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14894324 ↗
• InjuryMar 3, 2022Stretched; Unraveled Material; Detachment of Device or Device Component; Stretched; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE COIL WAS DEPLOYED AS THE THIRD AND FINAL COIL. MULTIPLE DEPLOYMENT AND RE-SHEATHING ATTEMPTS WERE MADE WHEN THE PHYSICIAN NOTED THE COIL FILE STRETCHED AND DETACHED. ULTIMATELY IT SEEMED THE COIL DETACHED WITH A LONG TETHER REMAINING PROXIMAL TO THE END OF THE COIL. THE PROXIMAL 1-2CM OF COIL WERE LEFT OUT OF THE ANEURYSM WITH AN ADDITIONAL PORTION LEFT PROXIMAL TO THE LVIS JR. STENT, WHICH HAD ALREADY BEEN DEPLOYED, JAILING THE MICROCATHETER BEING USED TO COIL. AS WELL, THIS REMAINING TETHER (OF AROUND 5-10CM) WAS LEFT PROXIMAL TO THE LVIS JR. AND ULTIMATELY TACKED DOWN WITH AN ATLAS STENT, PROXIMAL TO THE ORIGINAL COIL/STENT CONSTRUCT. MULTIPLE ATTEMPTS AT CLEARING THE MICROCATHETER WITH A GUIDEWIRE FAILED TO DISLODGE THE TETHER, WHICH WAS STILL IN THE MICROCATHETER. A SNARE WAS ALSO UTILIZED AROUND THE MICROCATHETER IN ORDER TO SNARE THE TETHER OR COIL TO REMOVE IT, HOWEVER, THE SNARE WOULD NOT NAVIGATE THE ANATOMY AND COULD NOT REACH THE SITE. ULTIMATELY IT WAS DECIDED TO TACK DOWN THE TAIL WITH AN ATLAS STENT. THE PATIENT IS DOING WELL AT END AND POST OF PROCEDURE. NO FURTHER TREATMENT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13662184 ↗
• InjuryMar 20, 2020Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A PARTIALLY THROMBOSED P-COM ANEURYSM. AFTER PLACEMENT OF THE EMBOLIZATION COIL, THE COIL COULD NOT BE DETACHED WITH THREE DIFFERENT DETACHMENT CONTROLLERS OR A 9-VOLT BATTERY. DURING THE ATTEMPT TO REMOVE THE COIL, THE COIL STRETCHED. THE COIL WAS BROKEN OFF AND TACKED AGAINST THE VESSEL WALL WITH THREE (3) STENTS. APPROXIMATELY 1 CM OF IMPLANT COIL EXTENDED INTO THE P-COM AND ANOTHER 6 CM OF STRETCHED COILS BACKED DOWN INTO THE CAVERNOUS SEGMENT. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL SEQUELA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862350 ↗
• MalfunctionMay 6, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT FRICTION WAS ENCOUNTERED DURING THE ADVANCEMENT OF THE 3RD COIL IN A SUBARACHNOID HEMORRHAGE ANTERIOR COMMUNICATING ARTERY ANEURYSM, AND THE COIL GOT STUCK INSIDE THE CATHETER. DURING REMOVAL, THE COIL DETACHED IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584671 ↗