PROGAV 2.0 FX603TRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04041906503239), received between Dec 10, 2020 and Aug 3, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (20 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.

• InjuryAug 3, 2026Obstruction of Flow

  It was reported that a proGAV 2.0 Shuntsystem (#FX603T) was implanted on 01/15/2024.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on 07/04/2026.No patient complications were reported as a result of the revision procedure.

  Patient problems: Hydrocephalus

  MAUDE report 50117879 ↗
• InjuryJul 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25716361 ↗
• InjuryMay 22, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25260546 ↗
• InjuryMay 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2025. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO REASON FOR THE EXPLANTATION WAS GIVEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25200180 ↗
• InjuryFeb 23, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 24414603 ↗
• InjuryDec 1, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) 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 NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 23679793 ↗
• InjuryAug 11, 2025Microbial Contamination of Device; Obstruction of Flow; Microbial Contamination of Device; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND HAD AN INFECTION. 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 22773120 ↗
• InjuryJun 5, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND 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 22149030 ↗
• InjuryMay 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2024. 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 22051993 ↗
• InjuryNov 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNTASSISTANT (PART OF #FX603T) CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.

  Patient problems: Hydrocephalus

  MAUDE report 20704970 ↗
• MalfunctionAug 12, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) SHOWED DEVIATION IN THE FLOW BEFORE IMPLANTATION. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION. A REPLACEMENT PRODUCT COULD BE USED TO COMPLETE THE OPERATION SUCCESSFULLY. AGE: 50 YEARS HEIGHT: 170 CM WEIGHT: 70 KG GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19960635 ↗
• InjuryMay 16, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (# FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-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: 4 YEARS, 10 MONTHS. WEIGHT: 18.2 KGS. HEIGHT: 95 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19335303 ↗
• InjuryMay 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX221T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE. 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: 2 YEARS, 4 MONTHS. WEIGHT: 10 KGS. HEIGHT: 81 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19226249 ↗
• InjuryApr 24, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. 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: 55 YEARS. WEIGHT: 100 KGS. HEIGHT: 180 CM. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 19176016 ↗
• InjuryMar 6, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON 02/09/2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 YEARS . WEIGHT: 35 KGS. HEIGHT: 125 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18846644 ↗
• InjuryFeb 13, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON 01/19/2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 31 YEARS. WEIGHT: 62 KGS. HEIGHT: 177 CM. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18695354 ↗
• InjuryDec 18, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#: FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 58 YEARS, WEIGHT: 67 KGS, HEIGHT: 172, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18347369 ↗
• MalfunctionSep 21, 2023Mechanical Problem; Mechanical Problem

  RECEIPT OF INFORMATION THAT A PROGAV 2.0 SHUNT SYSTEM (FX603T) COULD NOT BE ADJUSTED BEFORE USE. THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788875 ↗
• InjurySep 12, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE, ADJUSTMENT DIFFICULTIES. 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: 85 YEARS. WEIGHT: 75 KILOGRAMS. HEIGHT: 160 CENTIMETERS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17731391 ↗
• InjuryJun 29, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) 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 MAY 28, 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 58 YEARS WEIGHT: UNKNOWN HEIGHT: UNKNOWN GENDER: MALE

  Patient problems: Hydrocephalus

  MAUDE report 17233451 ↗
• InjuryMay 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX603T) WOULD BE IMPLANTED DURING A PROCEDURE ON (B)(6), 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. THIS PROBLEM WAS DETECTED DURING THE OPERATION OF THE PATIENT. THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 16961285 ↗
• InjuryFeb 7, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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.

  Patient problems: Hydrocephalus

  MAUDE report 16311878 ↗
• InjuryDec 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A CONTROL RESERVOIR (PART # FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM INCLUDING THE RESERVOIR, WAS BELIEVED TO BE CLOGGED. 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: 44 YEARS, HEIGHT: 180 CENTIMETERS (CM), WEIGHT: 85 KILOGRAMS (KG), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 15936508 ↗
• InjuryNov 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX603T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN BLOCKAGE. 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. (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 15848506 ↗
• InjuryAug 11, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX603T) 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 COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 60 YEARS, HEIGHT: 190 CENTIMETERS (CM), WEIGHT: 75 KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15214333 ↗