HydroSoft 3D 7110-0308-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00816777025470), received between Jun 30, 2017 and Feb 6, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED DURING A COIL EMBOLIZATION PROCEDURE, THE SECOND TO THE LAST COIL WOULD NOT DETACH USING A DETACHMENT CONTROLLER. WHEN THE COIL WAS PULLED BACK, IT DETACHED INSIDE THE MICROCATHETER, AND THE COIL WAS PUSHED INTO THE ANEURYSM USING A GUIDEWIRE. ANOTHER COIL WAS PLACED IN THE ANEURYSM, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327398 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY, THE EMBOLIZATION COIL WAS USED TO TREAT RIGHT POSTERIOR COMMUNICATING ARTERY MEASURING 3.45MM X 2.93MM X 3.06MM AND NECK SIZE OF 2.59MM. REPORTEDLY, FOLLOW-UP ANGIOGRAM REVEALED INTERVAL COIL COMPACTION WITHOUT CHANGE IN ANEURYSM MORPHOLOGY OR SIZE, WHICH RESULTED IN RECANALIZATION OF THE ANEURYSM WITH DOG-EAR FILLING. SUBJECT UNDERWENT RETREATMENT WITH A FLOW DIVERTER. THE SUBJECT COMPLETED 18-MONTH FOLLOW-UP AND EXITED THE STUDY ON (B)(6) 2020 WITH NO ADDITIONAL ADVERSE EVENTS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 20582893 ↗
• InjuryJul 15, 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 A PATIENT TREATED WITH EMBOLIZATION COIL IMPLANTS EXPERIENCED A SMALL BASAL RECURRENCE, WHICH WAS NOTICED 226 DAY POST OP ON DSA. FURTHER STENT EMBOLIZATION WAS PERFORMED ON (B)(6) 2022. THE OUTCOME WAS REPORTED TO BE "RESOLVED WITHOUT SEQUELAE."

  Patient problems: Aneurysm

  MAUDE report 19744051 ↗
• InjurySep 7, 2021Difficult 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

  IT WAS REPORTED THE PATIENT PRESENTED WITH A RUPTURED ACOM ANEURYSM MEASURING 3.15 X2.93. THE PHYSICIAN USED A HYDROSOFT 3D 3X8 COIL. THE PHYSICIAN STATED THAT THE COIL OFFERED RESISTANCE DURING PLACEMENT ATTEMPTS AND BEGAN TO STRETCH. THE PUSHER WIRE FRACTURED DURING THE ATTEMPT TO REMOVE THE DEVICE. THE REMAINDER OF THE DEVICE WAS RETRIEVED WITH A COMANECHI AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE IT WITH A SNARE AND ASPIRATION. THE ANEURYSM WAS NOT PRESENT ON FINAL IMAGING. THE PATIENT RETURNED (B)(6) 2021 FOR DIAGNOSTIC IMAGING. THE ANEURYSM WAS NOT VISIBLE, SO NO FURTHER TREATMENT WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436935 ↗
• InjuryMar 27, 2020Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A CHOROIDAL ANEURYSM. DURING PLACEMENT OF THE EMBOLIZATION COIL, THE ANEURYSM WAS PERFORATED. DURING THE ATTEMPT TO RETRACT THE COIL, THE COIL STRETCHED AND THEN DETACHED. ANOTHER COIL WAS PLACED IN THE ANEURYSM, WHICH WAS SUCCESSFUL IN STOPPING THE EXTRAVASATION. THE DETACHED COIL SEGMENT WAS THEN REMOVED FROM THE PATIENT WITH A STENT RETRIEVER. THE PATIENT WOKE UP FROM ANESTHESIA. THE PATIENT WAS REPORTED TO HAVE HAD A STROKE, BUT WAS SLOWLY IMPROVING.

  Patient problems: Neurological Deficit/Dysfunction; Perforation of Vessels

  MAUDE report 9892316 ↗
• InjuryJan 10, 2020Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT BALLOON-ASSISTED COIL EMBOLIZATION WAS ATTEMPTED AS TREATMENT FOR A RUPTURED, WIDE-NECKED RIGHT POSTERIOR COMMUNICATING ARTERY (P-COM) ANEURYSM. AFTER POSITIONING THE 3RD COIL IN THE ANEURYSM, THE COIL WOULD NOT DETACH. THE COIL WAS WITHDRAWN AND RE-ADVANCED TO ATTEMPT ANOTHER DETACHMENT, WITHOUT SUCCESS. THE COIL WAS THEN WITHDRAWN INTO THE MICROCATHETER AND THE ENTIRE SYSTEM WAS REMOVED TOGETHER. DURING THE REMOVAL OF THE SYSTEM, THE PREVIOUSLY PLACED COILS PROLAPSED INTO THE RIGHT INTERNAL CAROTID ARTERY. ADDITIONAL COILS WERE THEN PLACED IN THE ANEURYSM THROUGH A NEW MICROCATHETER; HOWEVER, THE PROLAPSED COILS COULD NOT BE PUSHED BACK INTO THE ANEURYSM AND A STENT WAS IMPLANTED IN THE PARENT ARTERY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT. THE PATIENT WAS REPORTED TO BE STABLE AND DID WELL, POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578403 ↗
• InjuryJul 23, 2019Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Migration; Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING BALLOON-ASSISTED COIL EMBOLIZATION OF AN ACOMM ANEURYSM, THE IMPLANT COIL DID NOT DETACH AND DURING WITHDRAWAL, THE COIL STRETCHED AND THEN DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS RETRACTED; HOWEVER, THE COIL WAS NOT ABLE TO BE FULLY CAPTURED WITH THE MICROCATHETER. ATTEMPTS WERE MADE WITH A SNARE DEVICE TO RETRIEVE THE COIL, BUT THEY WERE UNSUCCESSFUL AND THE COIL ADVANCED TO THE MCA BIFURCATION. A STENTRIEVER WAS USED TO SUCCESSFULLY REMOVE THE DETACHED COIL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818874 ↗
• InjuryAug 14, 2018Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT DURING A BALLOON ASSISTED TREATMENT OF A RIGHT SIDE POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE 2ND EMBOLIZATION COIL BECAME UNRESPONSIVE TO THE PHYSICIAN'S MOVEMENT. THE COIL WAS NOTED TO HAVE STRETCHED, AS SEEN ON AN ANGIOGRAM. THE STRETCHED COIL WAS INTENTIONALLY DETACHED WITH THE CONTROLLER IN THE MICROCATHER. THE COIL WAS SUCCESSFULLY RETRIEVED WITH TWO (2) SEPARATE SNARE DEVICES AND THE PATIENT WAS REPORTED TO HAVE EXCELLENT BLOOD FLOW PAST THE ANEURYSM; HOWEVER, CLOTTING AND VASOSPASM OCCURRED DURING THE EXTENDED TIME IT TOOK TO REMOVE THE COIL (4 HOURS). REOPRO WAS ADMINISTERED TO TREAT THE CLOT, AND VERAPAMIL WAS USED FOR THE VASOSPASM. DURING FOLLOW-UP THE DAY AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A SMALL STROKE, BUT IS OKAY, ALERT, AND TALKING.

  Patient problems: Neurological Deficit/Dysfunction; Thrombus

  MAUDE report 7783110 ↗
• InjuryJun 30, 2017Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS PERFORMED ON A RUPTURED ANEURYSM. AFTER ALMOST ALL OF THE SECOND COIL HAD BEEN PLACED, THE DECISION WAS MADE TO EXCHANGE THE COIL. DURING RETRACTION, THE COIL DETACHED, LEAVING A SEGMENT OF THE COIL OUTSIDE THE ANEURYSM. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH A SNARE DEVICE; HOWEVER, THE SNARE BROKE. A SECOND SNARE WAS USED TO RETRIEVE BOTH THE COIL AND THE BROKEN SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6683042 ↗