proGAV 2.0® FX417TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04041906136598), received between Sep 14, 2020 and Feb 10, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 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) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. 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.

  Patient problems: Hydrocephalus

  MAUDE report 21347039 ↗
• InjuryDec 15, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED DIFFICULTIES IN ADJUSTMENT DURING A FOLLOW-UP CONSULTATION. NO FURTHER ACTION IS PLANNED, THE PATIENT IS STABLE AND THE VALVE REMAINS IMPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 18334711 ↗
• InjurySep 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THEVALVE CAUSED AN OVERDRAINAGE. 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: 32 YEARS. HEIGHT: 158 CENTIMETERS. WEIGHT: BETWEEN 150 -180 KILOGRAMS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17747847 ↗
• MalfunctionApr 26, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX417T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6), 2023. ACCORDING TO THE COMPLAINANT, THE VALVE COULD NOT BE FILLED BEFORE USE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hydrocephalus

  MAUDE report 16820391 ↗
• InjuryJan 27, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 17 YEARS, HEIGHT: 153 CENTIMETERS (CM), WEIGHT: 57 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2022-00436 AND 3004721439-2022-00437.

  Patient problems: Hydrocephalus

  MAUDE report 16258263 ↗
• InjuryJan 7, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A SHUNT DYSFUNCTION. 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: (B)(6) YEARS, HEIGHT: 148 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: UNKNOWN. ITS THE SAME PATIENT AS MDR ID # 3004721439-2021-00346 AND MDR ID # 3004721439-2021-00347.

  Patient problems: Hydrocephalus

  MAUDE report 13193802 ↗
• MalfunctionDec 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH AN IMPLANTED PROGAV 2.0 (FX417T). DESCRIPTION OF THE PROBLEM: THE FEATURE OF THIS PRODUCT IS THAT THE LOCK MECHANISM WORKS UP TO 3 TESLA BY MRI LOCK, AND THE PRESSURE DOES NOT CHANGE. HOWEVER, THE PRESSURE OF THE IMPLANT IN THE PATIENT CHANGES EVERY TIME AN MRI IS PERFORMED. NO SAMPLE (PRODUCT DATA) AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 12908979 ↗
• InjuryNov 16, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 VALVE (PART # FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS NOT ABLE TO BE ADJUSTED. 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: UNKNOWN, HEIGHT: 192 CENTIMETERS (CM), WEIGHT: (B)(6) (KG), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12821226 ↗
• InjuryJun 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX417T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A PROBLEM WITH THE ADJUSTABILITY. 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. HEIGHT: 90 CM. WEIGHT: (B)(6) KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12093700 ↗
• InjuryMay 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV046T + FX417T SHUNT SYSTEM. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING WITH BLOCKAGE. 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. PATIENT INFORMATION: (B)(6) YEARS. EXPLANTATION: (B)(6) 2021. THE SAME EVENT: MEDWATCH#3004721439-2021-00133.

  Patient problems: Head Injury; Hemorrhage/Blood Loss/Bleeding; Hydrocephalus

  MAUDE report 11849821 ↗
• InjuryMay 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV046T + FX417T SHUNT SYSTEM. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING WITH BLOCKAGE. 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. PATIENT INFORMATION: AGE: (B)(6) YEARS. EXPLANTATION: (B)(6) 2021. THE SAME EVENT: MEDWATCH#3004721439-2021-00134.

  Patient problems: Head Injury; Hemorrhage/Blood Loss/Bleeding; Hydrocephalus

  MAUDE report 11849734 ↗
• InjuryApr 15, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX417T) AND (3) PROSA (PART # FV701T) (REF. ASSOCIATED MDR ID 3004721439-2021-00084, 3004721439-2021-00085, AND 3004721439-2021-00086 WERE IMPLANTED DURING A PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, A BLOCKAGE WAS SUSPECTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 AND HAD THE PROGAV 2.0, THE (3) PROSA VALVES, AS WELL AS A SENSOR RESERVOIR (PART # FV912X; THIS DEVICE, NOR SIMILAR PRODUCT, MARKETED IN USA) REMOVED. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT INFORMATION WERE SUBMITTED. REFERENCE ASSOCIATED MDR ID 3004721439-2021-00084, 3004721439-2021-00085, AND 3004721439-2021-00086.

  Patient problems: Hydrocephalus

  MAUDE report 11675597 ↗
• InjurySep 14, 2020Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  THE COMPLAINANT REPORTED THAT A PROGAV 2.0 WITH DISTAL CATHETER (PART # FX417T) AND A SPRUNG RESERVOIR SET W/DISTAL CATHETER (PART # FV046T) (REF. ASSOCIATED MDR ID 3004721439-2020-00185) WERE PLACED IN A PATIENT SOMETIME IN (B)(6) 2019. ON (B)(6) 2020 THE PHYSICIAN OBSERVED A DEVICE OCCLUSION, BUT NOTED NO PROBLEM WITH THE VALVE OR CATHETER AS CEREBROSPINAL FLUID WAS DRAINED WHEN THE SURGEON REMOVED THE PRODUCT. THE PHYSICIAN STATED THAT THE TIP OF THE ABDOMINAL CAVITY CATHETER WAS LIKELY BLOCKED IN THE ABDOMEN. NO KNOWN PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Hydrocephalus

  MAUDE report 10532289 ↗