proGAV® FV438TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906132514), received between Oct 28, 2020 and Jan 26, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # (B)(4)) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE AND WAS UNABLE 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: 90 CENTIMETERS (CM), WEIGHT: (B)(6) (KG), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13359349 ↗
• InjuryJan 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV (PART # (B)(4)) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT DATA: AGE: (B)(6), WEIGHT: 16 KILOGRAMS (KG), HEIGHT: (B)(6) (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13260881 ↗
• InjuryJan 6, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV ((#FV438T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), HEIGHT: 85 CM, WEIGHT: (B)(6) KG, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 13177308 ↗
• InjuryJan 3, 2022Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV (PART # FV438T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, A BLOCKAGE OF THE VALVE WAS SUSPECTED AND THE VALVE WAS ONLY PARTIALLY ADJUSTABLE. 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: (B)(6), WEIGHT: (B)(6), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13143867 ↗
• InjurySep 14, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF POSTOPERATIVE BLOCKAGE OR UNDER-DRAINAGE. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014. THE EXPLANT DATE WAS (B)(6) 2016. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 173 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12468634 ↗
• InjuryJul 19, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  INVESTIGATION IS COMPLETED.

  Patient problems: Hydrocephalus

  MAUDE report 12189646 ↗
• InjuryFeb 3, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS PROBLEM WITH A PROGAV VALVE. 2 YEARS AFTER SHUNT INSERTION, A CLINICALLY SIGNIFICANT OVERDRAINAGE APPEARED. THE VALVE WAS ADJUSTED NEW, BUT AFTER 2 MONTH, THE OVERDRAINAGE WAS PRESENT, TOO. AT THIS TIME THE ADJUSTMENT WAS NOT FURTHER POSSIBLE. PATIENT INFORMATION: AGE: (B)(6) YEARS, HEIGHT: 98 CM, WEIGHT: (B)(6) KG, GENDER: UNKNOWN. IMPLANTATION: (B)(6) 2018, EXPLANTATION: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 11275716 ↗
• InjuryOct 28, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV VALVE. THE PROBLEM - ADJUSTMENT INABILITY OF A PROGRAMMABLE ELEMENT (INABILITY TO CHANGE THE SHUNT PRESSURE). PATIENT INFORMATIONS: AGE: (B)(6) YEARS. WEIGHT: (B)(6) KG. HEIGHT: 98 CM. GENDER: UNKNOWN. IMPLANTATION SIDE - RETROAURICULAR. THE VALVE WAS IMPLANTED PARALLEL TO THE BODY AXIS. INITIAL SETTING AT IMPLANTATION WAS 8CMH20. 08.08.2019 ADJUSTED: 8->10CMH20 12.12.2019 ADJUSTED: 10->11CMH20, HIGHER SETTING COULD NOT BE REACHED. 09.2020 - SYMPTOMS OF THE OVERDRAINAGE HAVE APPEARED. VALVE SETTING COULD NOT BE ADJUSTED. THIS FACT FORCED THE DECISION TO REPLACE THE VALVE. COMPLETE MIETHKE SHUNT SYSTEM WAS IMPLANTED (PROGAV+SHUNTASSISTANT20 WERE IMPLANTED). IMPLANTATION DATE - (B)(6) 2019. EXPLANTATION DATE - (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10748193 ↗