proGAV 2.0® FX410TRecalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 04041906136529), received between Jun 19, 2018 and Sep 28, 2026 — classified as 116 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (83 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 25 most recent of 119 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Infusion or Flow Problem

  It was reported that a SHUNTASSISTANT 2.0 (#FX103T) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an over drainage.The patient underwent a revision procedure on (b)(6) 2026.Related to MedWatchNo: 3004721439-2026-00276.

  Patient problems: Hydrocephalus

  MAUDE report 50913391 ↗
• InjuryAug 21, 2026Physical Resistance/Sticking

  It was reported that a proGAV 2.0 valve (#FX410T) was implanted on (b)(6) 2024.According to the complainant, the valve had adjustment difficulties. The patient underwent a revision procedure on (b)(6) 2026.The sample will be returned for examination.This report is filed under AIC reference (b)(4).

  Patient problems: Hydrocephalus

  MAUDE report 50379774 ↗
• InjuryJun 23, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE(#FX410T) WAS IMPLANTED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. 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 25594699 ↗
• InjuryMay 18, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED IN (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS # 3004721439-2026-00142.

  Patient problems: Hydrocephalus

  MAUDE report 25200134 ↗
• InjuryMay 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON 04/14/2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS # 3004721439-2026-00135.

  Patient problems: Hydrocephalus

  MAUDE report 25200067 ↗
• InjuryMar 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. SAME EVENT AS # 3004721439-2026-00056

  Patient problems: Hydrocephalus

  MAUDE report 24546400 ↗
• InjuryMar 9, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED TOGETHER WITH AN M.BLUE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVES CAUSED AN OVERDRAINAGE. 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 SAME EVENT AS MEDWATCH NO.: 3004721439-2026-00058.

  Patient problems: Hydrocephalus

  MAUDE report 24546192 ↗
• InjuryMar 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 24545854 ↗
• InjuryJan 8, 2026Defective Component; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2 (PART # UNKNOWN) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS EXPLANTED ON (B))6) 2025 FOR AN UNSPECIFIED REASON. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 24007377 ↗
• InjuryDec 1, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT/PATIENT AS #3004721439-2025-00355.

  Patient problems: Hydrocephalus

  MAUDE report 23679755 ↗
• InjurySep 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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. SAME EVENT AS # 3004721439-2025-00268.

  Patient problems: Hydrocephalus

  MAUDE report 23051281 ↗
• InjuryAug 29, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS MEDWATCH NO.: 3004721439-2025-00245.

  Patient problems: Hydrocephalus

  MAUDE report 22921148 ↗
• InjuryAug 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE 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. SAME EVENT AS # 3004721439-2025-00215.

  Patient problems: Hydrocephalus

  MAUDE report 22698085 ↗
• InjuryMay 2, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT PROBLEMS. 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 21949364 ↗
• InjuryMar 31, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M.BLUE (PART #FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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. ASSOCIATED MEDWATCH REPORT: 2916714-2025-00006 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Hydrocephalus

  MAUDE report 21730999 ↗
• InjuryMar 31, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 21730672 ↗
• InjuryMar 31, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 21730596 ↗
• InjuryMar 11, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (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 21571729 ↗
• InjuryMar 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE 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. SAME EVENT AS # 3004721439-2025-00085.

  Patient problems: Hydrocephalus

  MAUDE report 21509820 ↗
• InjuryMar 3, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A M. BLUE PLUS VALVE (PART# FX804T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THERE WAS DIFFICULTY REPROGRAMMING BOTH VALVES. THE PATIENT'S DEVICE NEVER HAD ISSUES BEING REPROGRAMMED AS SUCH THE TREATING PHYSICIANS WANTED TO CLOSELY MONITOR THE PATIENT'S PROTEIN LEVEL AND STATED THAT THEY DID NOT WANT TO PERFORM ANY ADDITIONAL MEDICAL INTERVENTIONS AT THAT TIME OR TAKE ANY FURTHER ACTIONS. REPORTEDLY ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE OFFICE WITH THE SALES REPRESENTATIVE PRESENT TO ASSIST WITH ANY RE-PROGRAMMING, AND IT WAS ON THIS DAY THAT THE TREATING PHYSICIANS DECIDED TO MEDICALLY INTERVENE. THE ADVERSE EVENT IS FILED UNDER (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 21507176 ↗
• InjuryJan 15, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6)2024. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME INCIDENT AS MEDWATCH#3004721439-2024-00424.

  Patient problems: Hydrocephalus

  MAUDE report 21157260 ↗
• InjuryNov 27, 2024Excess Flow or Over-Infusion; Physical Resistance/Sticking; Excess Flow or Over-Infusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE ON 03/14/2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER- AND OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE 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. SAME EVENT AS # 3004721439-2024-00363/ (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 20800292 ↗
• InjuryNov 25, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE/UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 20774798 ↗
• InjuryOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) SHOWED A MALFUNCTION. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20546254 ↗
• InjuryOct 21, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 12 YEARS, 10 MONTHS WEIGHT: 51 KGS HEIGHT: 158 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20492582 ↗