PROGAV 2.0 FX596TRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04041906503536), received between Feb 10, 2021 and Sep 14, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Obstruction of Flow

  It was reported that a proGAV 2.0 Shuntsystem (#FX596T) was implanted on (b)(6) 2020.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2026.

  Patient problems: Hydrocephalus

  MAUDE report 50751990 ↗
• MalfunctionApr 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER (#FX596T) WAS TO BE IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE PRECHAMBER CAUSED MALFUNCTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25001750 ↗
• InjuryDec 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. 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 23805297 ↗
• InjuryJul 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, THAT A PROGAV 2.0 SHUNT SYSTEM (#FX596T) PRIOR TO IMPLANTATION INTO THE PATIENT, NO SALINE FLOWED OUT DURING THE SHUNT DRAINAGE TEST. THE CATHETER IS SUSPECTED TO BE BLOCKED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE DELAYED PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629092 ↗
• InjuryJun 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM(#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 22309436 ↗
• InjuryFeb 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#: FX596T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE RELEASE FOR INVESTIGATION FROM THE CLINIC WAS SUBMITTED AND THE SAMPLE WAS INVESTIGATED.

  Patient problems: Hydrocephalus

  MAUDE report 21344860 ↗
• InjuryFeb 7, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 6 MONTHS. HEIGHT: 55 CM. WEIGHT: 8.5 KG. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18657938 ↗
• InjuryJan 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 MONTHS WEIGHT: 3.28 KGS HEIGHT: 57.5 CM GENDER: MALE

  Patient problems: Hydrocephalus

  MAUDE report 18498066 ↗
• InjuryJan 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 3 MONTHS GENDER: FEMALE

  Patient problems: Hydrocephalus

  MAUDE report 18425467 ↗
• InjuryJan 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023 ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 MONTHS WEIGHT: 4.4 KILOGRAMS HEIGHT: 59 CENTIMETERS GENDER: UNKNOWN

  Patient problems: Hydrocephalus

  MAUDE report 18425334 ↗
• InjuryNov 3, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN 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: 3 YEARS AND 3 MONTHS. HEIGHT: 93 CENTIMETERS. WEIGHT: 14 KILOGRAMS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18066122 ↗
• InjuryAug 23, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 4 MONTHS, WEIGHT: 4.9 KILOGRAMS (KG), HEIGHT: 57 CENTIMETERS (CM), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17608089 ↗
• InjuryMay 17, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDERDRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6)2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 5 MONTHS. WEIGHT: 5.3 KILOGRAMS (KG). HEIGHT: 62 CENTIMETERS (CM). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16950528 ↗
• InjuryApr 19, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FV596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND NON-ADJUSTABILITY. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 MONTHS WEIGHT: 3.2 KILOGRAMS (KG) HEIGHT: 62 CENTIMETERS (CM) GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16773431 ↗
• InjuryApr 3, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6), 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6), 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 MONTHS HEIGHT: UNKNOWN WEIGHT: UNKNOWN GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16663168 ↗
• InjuryNov 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER- DRAINAGE. 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: 14 YEARS, 11 MONTHS. HEIGHT: 168 CENTIMETERS (CM). WEIGHT: 50 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15849217 ↗
• InjuryOct 7, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 WAS BELIEVED TO BE NOT ADJUSTABLE IN THE PRESSURE SETTINGS. 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: 2 YEARS; HEIGHT: 87 CENTIMETERS (CM); WEIGHT: 11 KILOGRAMS (KG); GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 15566814 ↗
• InjurySep 24, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND DIFFICULT TO ADJUST. 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: 2 YEARS, 6 MONTHS, HEIGHT: 86 CENTIMETERS (CM), WEIGHT: 12 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15480938 ↗
• InjuryAug 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO HAVE ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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: 2 YEARS. HEIGHT: 80 CENTIMETERS (CM). WEIGHT: 10 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15214362 ↗
• InjuryMar 3, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: (B)(6). WEIGHT: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 13662871 ↗
• InjuryDec 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. 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: 80 CM. WEIGHT: (B)(6) KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 13077958 ↗
• InjuryJul 13, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX596T) 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 HAD AN ISSUE WITH ADJUSTABILITY. 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: 1 YEAR. HEIGHT: UNKNOWN, WEIGHT: UNKNOWN, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12158204 ↗
• InjuryJul 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN 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: (B)(6). HEIGHT: UNKNOWN. WEIGHT: (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12129139 ↗
• InjuryJul 7, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM(#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED AND NOT FURTHER ADJUSTABLE. 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: 160 CM WEIGHT: (B)(6) GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12128745 ↗
• InjuryJun 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYTSEM (PART # FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER/UNDER DRAINAGE AND/OR CLOGGED. 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: 65 CENTIMETERS (CM) WEIGHT: (B)(6) GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12046630 ↗