proGAV 2.0® FX434TRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04041906137328), received between Nov 4, 2020 and May 22, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WANTED TO BE IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM APPEARS TO HAVE BECOME BLOCKED DURING THE PROCEDURE. AS A RESULT, THE SHUNT COULD NOT BE USED, AND AN ADDITIONAL SHUNT HAD TO BE USED TO COMPLETE THE PROCEDURE. THE EVENT WAS CONSIDERED NON-SERIOUS BY THE CLIENT. PATIENT RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260351 ↗
• InjuryFeb 24, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX434T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. DUE TO AN INFECTIOUS DISEASE OF THE PATIENT, NO PRODUCT WAS RETURNED FOR EXAMINATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21447647 ↗
• InjuryAug 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX434T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 17442133 ↗
• InjurySep 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND WAS DIFFICULT TO ADJUST. REPORTEDLY, FOLLOWING THE PRIMARY SURGERY, THE PATIENT SHOWED NO IMPROVEMENT IN HYDROCEPHALUS, SO PRESSURE CHANGES WERE PERFORMED SEVERAL TIMES. AFTER THAT, WHEN THE DOCTOR TRIED TO CHANGE THE PRESSURE, THE PRESSURE COULD NOT BE CHANGED. THE DOCTOR COULD PUSH THE RESERVOIR, BUT FELT RESISTANCE. THE DOCTOR BELIEVES THAT THE PROTEIN COMPONENT MAY HAVE CLOGGED THE VALVE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 4 YEARS, 3 MONTHS; GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15464898 ↗
• InjuryDec 8, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS BLOCKED POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 170 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12964416 ↗
• InjuryOct 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FX434T - PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV. ACCORDING TO THE COMPLAINANT, WHEN THE CUSTOMER PULLED THE CATHETER TO PASS IT FROM HEAD SIDE TO ABDOMINAL CAVITY, CATHETER WAS BROKEN OFF. THE CATHETER WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12627430 ↗
• InjurySep 16, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF POSTOPERATIVE BLOCKAGE. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016. THE EXPLANT DATE WAS (B)(6) 2016. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12480873 ↗
• InjuryJun 15, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED SOMETIME IN 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A BLOCKAGE AND THE DEVICE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) HEIGHT: 103 CENTIMETERS (CM) WEIGHT: (B)(6) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12004009 ↗
• InjuryJun 15, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  APPROVAL FOR INVESTIGATION RECEIVED ON 10/11/2021, SO THE INVESTIGATION COULD BE DONE.

  Patient problems: Hydrocephalus

  MAUDE report 12002772 ↗
• InjuryApr 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATION: AGE: (B)(6) YEARS, WEIGHT: (B)(6) KG, HEIGHT: 140, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11711966 ↗
• InjuryMar 9, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  UPON RETURN OF THE COMPLAINT DEVICE FOR EXAMINATION AND THE ATTACHED QUESTIONNAIRE, THE SURGEON SUSPECTS AN OVERDRIANAGE OF THE SHUNT SYSTEM AND REPORTS DIFFICULTY ADJUSTING THE VALVE. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 11444874 ↗
• InjuryNov 16, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX434T) WAS USED DURING A HYDROCEPHALUS SHUNT PROCEDURE PERFORMED IN EARLY (B)(6) 2020. ACCORDING TO THE COMPLAINANT, APPROXIMATELY ONE (1) WEEK POST PROCEDURE, THE SHUNT EFFECT WAS NOTED AS BEING "NOT GOOD," WITH A SLOW REBOUND AFTER THE RESERVOIR WAS PRESSED DOWN. ALTHOUGH THE PRESSURE WAS REDUCED, THE VENTRICLE REMAINED LARGE WITH NO OBSERVABLE IMPROVEMENT. THE PATIENT UNDERWENT A REVISION SURGERY, DURING WHICH THE IMPLANTED DEVICE WAS REPLACED, TO RESOLVE THE ISSUE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10843185 ↗
• InjuryNov 11, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV (B)(4) SHUNT SYSTEM. THE SURGEON HAS REPORTED THAT THE VALVE IS NON-ADJUSTABLE. AGE: UNKNOWN; WEIGHT: UNKNOWN; HEIGHT: UNKNOWN; GENDER: UNKNOWN; DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10822709 ↗
• InjuryNov 4, 2020Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, FOLLOWING IMPLANTATION OF THE SHUNT, THE PATIENT EXPERIENCED FEVER AND INFECTION SYMPTOMS. THE PATIENT WAS UNSUCCESSFULLY TREATED WITH ANTIBIOTICS, WHICH RESULTED IN THE REMOVAL OF THE DEVICE, THREE (3) MONTHS POST IMPLANTATION. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 10784788 ↗