HydroSoft 3D 7110-0304-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777025456), received between Sep 6, 2023 and Nov 10, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY: RECEIVED RETREATMENT DATA FROM THE STUDY TEAM FOR REVIEW. EVENT INFORMATION EVENT DATE: 04/NOV/2020 PROCEDURE DATE: (B)(6) 2019 TARGET ANEURYSM INFORMATION: ANEURYSM LOCATION: POSTERIOR COMMUNICATING (PCOM) OTHER ANEURYSM LOCATION: ANEURYSM SIDE: LEFT HEIGHT: 4.7MM WIDTH: 2.3MM DEPTH: 2.6MM NECK SIZE: 1.9MM DOME TO NECK RATIO: 1.21MM. EVENT DESCRIPTION: CEREBRAL ANGIOGRAPHY DEMONSTRATED COIL COMPACTION AND RECURRENCE AT THE BASE OF THE ANEURYSM. THE SUBJECT UNDERWENT RETREATMENT WITH CLIPPING. DEVICE INFORMATION THAT WAS USED IN INDEX PROCEDURE. AS IT CANNOT BE DETERMINED WHICH COIL DEVICE MAY HAVE IMPACTED THE ANEURYSM RECURRENCE THE HYDROSOFT 3D- 3X4 WAS CHOSEN AS A DEFAULT. THE OTHER COIL USED IN THE PROCEDURE WILL BE LISTED AS CONCOMITANT DEVICE. 1. HYDROSOFT 3D 3X4- DETACHED 2. HYDROSOFT 3D 1.5X2- DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649469 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY: BELOW EVENT WAS REVIEWED BY INDEPENDENT REVIEWER (CEA) AND WAS DETERMINED TO BE DEFINITELY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE. EVENT INFORMATION: EVENT TERM: ANEURYSM RECURRENCE EVENT #: 2 EVENT START DATE: 20/FEB/2020 POST OPERATIVE DAYS: 211 DAYS EVENT DESCRIPTION : RECURRENCE ORIGINALLY FOUND 2/20/2020. DURING A CONSULT ON 1/15/2021 SUBJECT DISCUSSED RECURRENCE AND WANTING TREATMENT. SUBJECT HAD A 1.6 X 1.4 MM RECURRENCE AT THE BASE OF THIS ANEURYSM. PER TREATING PHYSICIAN THE RECURRENCE HAD A VERY LOW RISK OF RUPTURE. HOWEVER, THE PATIENT REPORTS DEBILITATING ANXIETY ABOUT FUTURE ANEURYSM-RELATED EVENTS THAT CULMINATED IN AN INPATIENT HOSPITALIZATION LAST MONTH FOLLOWING A SUICIDE ATTEMPT. DESPITE THE LOW NATURAL HISTORY RISK OF THE RECURRENT ANEURYSM, SUBJECT EXPRESSED THEY COULD NOT HANDLE THE THOUGHT OF GOING THROUGH ANOTHER ANEURYSM RUPTURE, AND THAT TAKING THE RISK OF ANEURYSM RUPTURE TO ZERO WOULD DRAMATICALLY IMPROVE ANXIETY. EMBOLIZATION PERFORMED ON (B)(6) 2021. FOLLOW UP ANGIOGRAM ON 10/8/2021 SHOWED COMPLETE OCCLUSION WITH NO RECURRENCE. AE OUTCOME : RESOLVED WITHOUT SEQUELAE DEVICES USED: HYDR

  Patient problems: Aneurysm

  MAUDE report 20116750 ↗
• MalfunctionSep 6, 2023Component Missing; Component Missing

  SEE SECTION H10 FOR INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695077 ↗