proGAV 2.0® FX433TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04041906137311), received between Feb 10, 2022 and Sep 8, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Obstruction of Flow; Infusion or Flow Problem; Physical Resistance/Sticking; Obstruction of Flow; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 22991082 ↗
• InjurySep 5, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 22976820 ↗
• InjuryAug 29, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE CONNECTED VENTRICULAR CATHETER OF THE CONTROL RESERVOIR SLIPPED OFF. AN ADDITIONAL SURGERY WAS REQUIRED ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE. THE COMPLAINED DEVICE IS STILL IMPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 22920981 ↗
• InjuryAug 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM(#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. 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 NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 22698173 ↗
• InjuryJul 3, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 22395046 ↗
• InjuryMay 20, 2025Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking; Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD A FUNCTIONAL DEVIATION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 22051986 ↗
• InjurySep 16, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED 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: 6 YEARS, 7 MONTHS . WEIGHT: 17.4. HEIGHT: 111 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 20225384 ↗
• InjuryNov 14, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM COULD NOT BE ADJUSTED AND SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE 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: 73 YEARS. WEIGHT: 57 KGS. HEIGHT: 171.4 CM. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18130260 ↗
• MalfunctionAug 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX433T) HAD ADJUSTMENT DIFFICULTIES. THE VALVE WAS NOT EXPLANTED. NO PATIENT WAS PLACED IN ANY HARM'S WAY.

  Patient problems: Hydrocephalus

  MAUDE report 17628538 ↗
• InjuryAug 11, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM(#FX443T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 77 YEARS, HEIGHT: 147 CENTIMETERS (CM), WEIGHT: 45 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17515235 ↗
• MalfunctionFeb 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX433T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AFTER A PREVENTIVE CHECK-UP USING MAGNETIC RESONANCE IMAGING (MRI), A PRESSURE SETTING ADJUSTMENT WAS BELIEVED AS BEING NEEDED DUE TO A DIFFERENT PRESSURE SETTING THAN REQUIRED. THE ADJUSTMENT DID NOT WORK. HOWEVER, THE PATIENT WAS FINE AND HAS NO SYMPTOMS, SO A REVISION WAS NOT NEEDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Hydrocephalus

  MAUDE report 13509852 ↗