proGAV 2.0® FX424TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04041906136949), received between Aug 17, 2021 and May 4, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A VETRICULAR CATHETER PART OF A PROGAV 2.0 SHUNT SYSTEM (#FX424T) TORE DURING PRE-SURGERY PREPARATIONS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070709 ↗
• MalfunctionMar 23, 2026Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV424T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE RESERVOIR COULD NOT BE PRIMED AND PRESSED. 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 24662273 ↗
• InjuryFeb 10, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PERITONEAL CATHETER FROM A PROGAV 2.0 SHUNT SYSTEM (#FX424T) BROKE INTRAOPERATIVELY. 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 24303636 ↗
• InjuryAug 11, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX424T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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. SAME INCIDENT AS MEDWATCH#3004721439-2025-00228.

  Patient problems: Hydrocephalus

  MAUDE report 22773359 ↗
• InjuryJun 10, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYSTEM (#FX424T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 71 YEARS, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 19499679 ↗
• InjuryFeb 7, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX424T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER-DRAINAGE. 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. REFERENCE ASSOCIATED MEDWATCH REPORT MDR ID # 3004721439-2023-00011.

  Patient problems: Hydrocephalus

  MAUDE report 16312461 ↗
• InjurySep 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX424T) 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) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 2 YEARS, 7 MONTHS. HEIGHT: 94 CENTIMETERS (CM). WEIGHT: 11 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH# 3004721439-2022-00281.

  Patient problems: Hydrocephalus

  MAUDE report 15465097 ↗
• InjuryFeb 17, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX424T) WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SURGEON WAS UNABLE TO ADJUST THE VALVE. REPORTEDLY, THE SURGEON PLACED THE VALVE IN A VERY DIFFICULT (MASTOID BONE) LOCATION, THEREFORE, IT WAS DIFFICULT TO LOCATE AND ADJUST THE VALVE. THE PATIENT FELT "BAD" AND THE ADJUSTMENT WAS WORSENING ACCORDING TO THE X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 13552808 ↗
• InjuryNov 4, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS BLOCKED POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2017; 18 DAYS LATER, THE MALFUNCTION WAS NOTED. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12752517 ↗
• InjuryAug 17, 2021Infusion 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) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO FURTHER PATIENT DATA ARE AVAILABLE. THE SAME EVENT: MEDWATCH# 3004721439-2021-00222.

  Patient problems: Hydrocephalus

  MAUDE report 12331155 ↗