proGAV 2.0® FX421TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04041906136635), received between Jan 13, 2021 and Mar 17, 2025 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 21618289 ↗
• InjurySep 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (# FX421T) CAUSED AN 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. AGE: 8 YEARS HEIGHT: 140 CM WEIGHT: 25 KG GENDER: MALE SAME EVENT/PATIENT AS 5237.

  Patient problems: Hydrocephalus

  MAUDE report 20224952 ↗
• InjuryApr 4, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON: UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 40 YEARS WEIGHT: 90 KGS HEIGHT: 175 CM GENDER: MALE

  Patient problems: Hydrocephalus

  MAUDE report 19044433 ↗
• InjuryDec 16, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV MADE NOISES POSTOPERATIVELY. THE VALVE WAS IMPLANTED IN (B)(6) 2017. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 13020736 ↗
• InjuryDec 3, 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: 174 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12928093 ↗
• InjuryOct 19, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF UNDERDRAINAGE POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNSPECIFIED DATE. TLHE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12656510 ↗
• InjuryOct 19, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF BLOCKAGE POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2017E. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 63 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12656493 ↗
• InjurySep 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYSTEM (FX421T)WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PROGAV SYSTEM WAS BELIEVED TO BE BLOCKING AND UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. 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).

  Patient problems: Hydrocephalus

  MAUDE report 12466572 ↗
• InjuryAug 30, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE AND ADJUSTMENT DIFFICULTIES WERE EXPERIENCED. 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: UNKNOWN. HEIGHT: (B)(6) CENTIMETERS (CM). WEIGHT: (B)(6) KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12387759 ↗
• InjuryMay 25, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND THE ADJUSTABILITY IS MALFUNCTIONING. 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. AGE: (B)(6) HEIGHT: 140 CM WEIGHT: (B)(6) GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11877286 ↗
• InjuryMay 11, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015 . ACCORDING TO THE COMPLAINANT, THE SHUNTSYSTEM WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE AND ADJUSTMENT PROBLEM. 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. AGE: (B)(6) YEARS. WEIGHT: (B)(6) KG. HEIGHT: (B)(6) CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11806923 ↗
• InjuryJan 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0 SHUNTSYSTEM. THE SURGEON SUSPECTED AN OVERDRAINAGE. PATIENT INFORMATIONS: AGE: (B)(6). HEIGHT: 170 CM. WEIGHT: (B)(6). GENDER: FEMALE. IMPLANTATION: (B)(6) 2015. REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 11164559 ↗