proGAV 2.0® FX466TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04041906137502), received between Apr 30, 2020 and Jun 2, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  WITH THE RETURN OF THE SAMPLE, NEW INFORMATION WAS MADE AVAILABLE. IT WAS REPORTED THAT A PROGAV 2.0 (#(B)(6)) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEAR, 5 MONTHS. HEIGHT: 80 CENTIMETERS (CM). WEIGHT: 10.4 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 17051429 ↗
• InjuryMay 25, 2023Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  INVESTIGATION COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 17002028 ↗
• MalfunctionJan 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PROGAV 2.0 WITH PED.PRECHAMBER (PART # FX466T) WAS TO BE USED DURING A SHUNT IMPLANT PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE CATHETER WAS LOOSE AND SEPARATING FROM THE RESERVOIR. THE ISSUE WAS NOTED WHEN THE DEVICE WAS REMOVED FROM THE BOX. NO SURGICAL DELAY OR PATIENT IMPACT OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: Hydrocephalus

  MAUDE report 16258304 ↗
• InjuryApr 30, 2020Patient-Device Incompatibility; Device-Device Incompatibility

  MY DAUGHTER HAS CONGENITAL HYDROCEPHALUS. HER VP SHUNT IS LOCATED ON THE LOWER RIGHT SIDE OF HER HEAD. ON (B)(6) 2019, SHE RECEIVED A PROGAV 2.0 VALVE SET AT 17 WITH INSTRUCTIONS TO HAVE THE SHUNT INTERROGATED AFTER AN MRI DUE TO POTENTIAL FOR THE MAGNET TO CHANGE THE VALVE SETTING. THERE WERE NO INSTRUCTIONS TO BE CAUTIOUS OF ELECTRONIC DEVICES THAT MAY INTERFERE WITH HER SHUNT. ON APRIL 11, 2020 I RECEIVED A PAIR OF (B)(6) WITH "INTUITIVE TOUCH CONTROL". BASIC FUNCTIONS ARE CONTROLLED BY SWIPING OR TOUCHING THE SURFACE AREA ON THE RIGHT EAR CUP. MY DAUGHTER HAS HAD A PAIR OF (B)(6) HEADPHONES SINCE (B)(6) 2019. SHE WANTED TO EXPERIENCE THE TOUCH CONTROL AND PLAYED AROUND WITH THEM FOR ABOUT 10 MINUTES. TWENTY MINUTES LATER SHE DEVELOPED AN ACUTE HEADACHE AND FATIGUE THAT ARE CONSISTENT WITH HER SHUNT MALFUNCTION OR FAILURE SYMPTOMS. SHE WAS HOSPITALIZED WITH VENTRICULAR DECOMPENSATION DUE TO OVER DRAINAGE WITHOUT SHUNT MALFUNCTION. COULD THE HEADPHONES CONTAIN A MAGNET THAT INTERFERED WITH THE PROGRAMMABLE CSF SHUNT? THE (B)(6) QUICK START GUIDE AND ONLINE OWNER'S GUIDE STATE THAT THE PRODUCT "CONTAINS A MAGNETIC MATERIAL AND TO CONSULT A PHYSICIAN ON WHETHER THIS MIGHT AFFECT IM

  Patient problems: Fatigue; Headache; Therapeutic Effects, Unexpected

  MAUDE report 10016969 ↗