proGAV 2.0® FX431TRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04041906137298), received between May 19, 2021 and Nov 10, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX432T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. 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 23511789 ↗
• InjuryMar 31, 2025Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT IS NOT WORKING PROPERLY. 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 RESULT IS STILL PENDING DUE TO THE LACK OF APPROVAL FOR THE EXAMINATION.

  Patient problems: Hydrocephalus

  MAUDE report 21732594 ↗
• InjuryMar 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR (PART# FX431T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE SHUNT WAS NOT WORKING PROPERLY. REPORTEDLY THE PATIENT UNDERWENT A REVISION ON (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21732593 ↗
• InjuryApr 4, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 61 YEARS, 5 MONTHS HEIGHT: 155 CM WEIGHT: 90 KG GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19044530 ↗
• InjuryOct 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTG SYSTEM (#FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE AND A BLOCKAGE. 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 YEARS. WEIGHT: 25 KILOGRAMS. HEIGHT: 124.4 CENTIMETERS. GENDER: UNKNOWN. SAME EVENT AS # 3004721439-2023-00300.

  Patient problems: Hydrocephalus

  MAUDE report 17959342 ↗
• InjurySep 6, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  REVISED PRODUCT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. PATIENT DATA: AGE: 52 YEARS. WEIGHT: 154 KG. HEIGHT: 167 CM. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 17691259 ↗
• InjurySep 6, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INVESTIGATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691023 ↗
• InjuryJul 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYSTEM (PART # FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. 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 17375425 ↗
• InjuryJul 14, 2023Partial Blockage; Partial Blockage

  INVESTIGATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327741 ↗
• InjuryOct 4, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR (PART # FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT'S CONDITION WAS NOTED AS BEING FINE. HOWEVER, VENTRICLE HYPERTROPHY WAS OBSERVED DURING A VISIT TO THE HOSPITAL IN (B)(6) 2016. THE ISSUE OCCURRED WHILE ATTEMPTING TO ADJUST THE PRESSURE VALUE OF THE VALVE. REPORTEDLY, THE PRESSURE VALUE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. 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 12573037 ↗
• InjurySep 24, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR (#FX431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS UNABLE TO BE ADJUSTED POSTOPERATIVELY. SURGEON TRIED TO CHANGE THE VALUE OF RELEASE PRESSURE, BECAUSE PATIENT HAD A HEADACHE. BUT, IT WAS NOT CHANGED. SEVERAL ATTEMPTS WERE MADE TO RE-ADJUST THE VALVE BUT THE OPENING PRESSURE SETTING DID NOT CHANGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016 TO REPLACE THE SHUNT. THE COMPLAINANT 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 12527079 ↗
• InjurySep 21, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS UNABLE TO BE ADJUSTED POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNSPECIFIED DATE. THE EVENT DATE WAS NOT NOTED. IT WAS POSSIBLE THAT THE ADJUSTABLE PART OF THE VALVE HAD BEEN DIRECTLY UNDER THE SUTURE LINE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12506586 ↗
• InjurySep 21, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF POSTOPERATIVE BLOCKAGE. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THE REVISION DATE WAS (B)(6) 2016. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12506493 ↗
• InjurySep 21, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF POSTOPERATIVE BLOCKAGE. THE PATIENT WAS ORIGINALLY IMPLANTED IN 2010. THE REVISION DATE WAS (B)(6) 2016. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 126 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12506399 ↗
• InjuryMay 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION: HEIGHT: 177 CM, WEIGHT: (B)(6). THE SAME EVENT: MEDWATCH#3004721439-2021-00136.

  Patient problems: Hydrocephalus

  MAUDE report 11848753 ↗