HydroSoft 3D 7110-0258-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816777025449), received between Jun 16, 2017 and Dec 16, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 23, 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 RAGE STUDY: EVENT INFORMATION: EVENT TERM: ANEURYSM RECANALIZATION EVENT START DATE: (B)(6) 2020 POST OPERATIVE DAYS: 50 DAYS EVENT DESCRIPTION: RECANALIZATION OF ANEURYSM IDENTIFIED ON IMAGING AND TREATED WITH RETREATMENT BY CLIPPING AE OUTCOME: SUBJECT WAS EXITED FROM THE STUDY ON (B)(6) 2021. THE EVENT WAS 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 19384379 ↗
• InjuryApr 7, 2023Unraveled Material; Unraveled Material

  AS REPORTED IN THE RAGE CLINICAL STUDY, THE PATIENT WAS BEING TREATED FOR ANEURYSM IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) THAT MEASURED 4MM AT THE DOME WITH OVERALL DIMENSION OF ABOUT 5.5MM AND NECK REGION ABOUT 2MM. DURING COIL SET UP, A COMPETITOR'S MICROCATHETER HAD DIFFICULTY ENTERING THE ANEURYSM AND WHEN THE GUIDEWIRE WAS REMOVED, THE MICROCATHETER JUMPED AND THE TIP WENT OUTSIDE THE ANEURYSM WALL AND THERE WAS EXTRAVASATION OF CONTRAST. A 4MM X 8CM HYDROFRAME COIL WAS THEN DEPLOYED FOLLOWED BY A 2.5MM X 8CM HYDROSOFT COIL WHERE IT WAS UNABLE TO DEPLOY THE LAST CENTIMETER. THE PHYSICIAN DECIDED TO DOWNSIZE TO A 2.5MM X 6CM AND ATTEMPTED TO REMOVE THE 2.5X8CM COIL RESISTANCE ENCOUNTERED AND THE COIL BECAME STRETCHED AND THE PUSHER WIRE DID NOT DETACH FROM THE COIL. THE HUB OF THE MICROCATHETER WAS CUT AND A GOOSENECK SNARE WAS ADVANCED AROUND THE PROXIMAL PART OF THE COIL MASS IN THE ACA BUT FAILED TO RETRIEVE THE COIL WHICH STRETCHED MORE. THE SNARE WAS REMOVED AND RUNS WITH AP AND LATERAL PROJECTION MADE THAT SHOWED NO FURTHER FILLING OF THE ANEURYSM AND NO EXTRAVASATION; HOWEVER, THERE APPEAR TO BE A METALLIC ARTIFACT WITHIN THE PETROUS ICA. THE PHYSICIAN DECIDED TO ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702600 ↗
• InjuryJun 16, 2017Difficult To Position; Difficult to Remove; Stretched; Difficult To Position; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING PLACEMENT OF THE 5TH EMBOLIZATION COIL TO TREAT A FISTULA IN THE CAVERNOUS PORTION OF THE INTERNAL CAROTID ARTERY, THE COIL WAS UNABLE TO FIT PROPERLY, DESPITE MULTIPLE ATTEMPTS TO REPOSITION IT. DURING AN ATTEMPT TO REMOVE THE COIL, THE COIL STRETCHED, BUT DID NOT DETACH. THE ENTIRE COIL WAS RETRIEVED WITH A SNARE DEVICE. IT WAS DETERMINED THAT THE FISTULA WAS 95% TREATED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT PATIENT'S STATUS IS REPORTED TO BE GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648673 ↗