HydroFrame 10 Advanced 7110-0410-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777025234), received between Dec 26, 2018 and May 24, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 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 POSSIBLY RELATED TO STUDY DEVICE AND UNLIKELY RELATED TO STUDY PROCEDURE. EVENT DESCRIPTION: SUBJECT HAD MILD SUPRATENTORIAL VENTRICULOMEGALY WITH FLUCTUATION IN CLINICAL STATUS. IT WAS CLARIFIED THE SUBJECT HAD 2 LUMBAR DRAINS INSERTED ONE ON (B)(6) 2022 AND ANOTHER ON (B)(6) 2022. NO SIGNIFICANT NEUROLOGICAL CHANGES, LUMBAR DRAIN REMOVED. EVENT TERM: HYDROCEPHALUS. EVENT START DATE: 09/MAR/2022. POST OPERATIVE DAYS: 33 DAYS. AE OUTCOME : RESOLVED WITHOUT SEQUELAE - DATE OF RESOLUTION WAS (B)(6) 2022 . DEVICES INVOLVED: HYDROFRAME LOT 2102181WF 4 X 10 ¿ MODEL 7110-0410-A2. HYDROFRAME LOT 0000091908 3 X 6 MODEL 7110-0306-A2. HYDROSOFT 3D LOT 0000139563 3 X 6 UNKNOWN MODEL . HYDROSOFT LOT 0000091013 2.5 X 6 MODEL 7210-0256-A2. HYDROSOFT LOT 0000109762 2 X 3 MODEL 7210-0203-A2. AS IT CANNOT BE DETERMINED WHICH COIL DEVICE MAY HAVE IMPACTED THE EVENT, HYDROFRAME 4X10, MODEL 7110-0410-A2 / LOT 2102181WF WAS CHOSEN AS A DEFAULT PRIMARY DEVICE. THE OTHER COILS USED IN THE PROCEDURE WILL BE LISTED AS CONCOMITANT DEVICES.

  Patient problems: Hydrocephalus

  MAUDE report 19397935 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RAGE CLINICAL STUDY, COIL COMPACTION WAS OBSERVED 16 MONTHS POST TREATMENT. RETREATMENT WAS PERFORMED TO TREAT THE COIL COMPACTION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882626 ↗
• MalfunctionFeb 18, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTICED THAT AN EMBOLIZATION IMPLANT COIL'S PACKAGE AND BOX HAD MISMATCHED LABELS. THE COIL WAS PLACED ASIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. THE PRODUCT DID NOT CONTACT THE PATIENT. NINE OTHER COILS USED DURING THE CASE WERE CHECKED AND THEIR PACKAGING WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563786 ↗
• MalfunctionDec 26, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT AFTER THE COIL HAD BEEN REMOVED FROM THE STERILE POUCH AND THE SCRUB TECH WAS GETTING READY TO PREP THE COIL, THE COMPANY REPRESENTATIVE NOTICED THAT THE COIL HOOP DID NOT LOOK "RIGHT" AND CHECKED THE DEVICE PACKAGE LABELS, WHICH INDICATED AN AZUR CX 18 PERIPHERAL COIL WAS INSIDE THE HYDROFRAME 10 NEURO COIL BOX. THE COIL WAS NOT USED IN THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8196849 ↗