proGAV 2.0® FX467TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906137083), received between Nov 10, 2021 and Jul 2, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE EVENT DESCRIPTION THE VALVE IS NOT CLICKING OR ABLE TO BE REPROGRAMMED. REPORTEDLY THE VALVE WAS ADJUSTED TO SETTING THAT THE PATIENT NEEDED BEFORE IMPLANTING IT. THE VALVE WORKED FINE WHEN IT WAS IN THE PACKAGING BUT NOW THAT IT IS IMPLANTED IN THE PATIENT IT WON'T CLICK AND THEREFORE, UNABLE TO BE REPROGRAMMED. REPORTEDLY THE PATIENT WILL UNDERGO A REVISION PROCEDURE BUT HAS YET TO BE SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 22382286 ↗
• InjuryJun 11, 2025Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking

  THE SHUNT IS STILL IMPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 22183933 ↗
• InjuryNov 15, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX467T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE 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: 69 YEARS, 1 MONTH, HEIGHT: 152.4 CENTIMETERS (CM), WEIGHT: 78.2 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15798377 ↗
• InjuryNov 11, 2022Undercorrection; Undercorrection

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 WITH CONTROL RESERVOIR (ITEM # FX467T) WAS IMPLANTED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING A CLINICAL VISIT ON (B)(6) 2022, THE PATIENT'S VALVE WAS NO LONGER ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE 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. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15781990 ↗
• InjuryJan 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX467T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: (B)(6), HEIGHT: (B)(6), WEIGHT: (B)(6), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 13195291 ↗
• InjuryNov 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV 2.0 WITH CONTROL RESERVOIR (PART # FX467T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD VALVE IMPLANTED OCCIPITALLY WITH A SETTING OF TWELVE (12). DESPITE MULTIPLE ATTEMPTS, THE VALVE WAS NOT ABLE TO BE ADJUSTED TO EIGHT (8). THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE SURGEON FELT THE LOCATION OF THE ORIGINAL VALVE, WHICH WAS DIRECTLY UNDER AN INCISION AND LOWER ON NECK WITH AT LEAST 1 CENTIMETER (CM) OF MUSCLE BETWEEN THE BONE AND VALVE, MAY HAVE CONTRIBUTED TO THE DIFFICULTY IN ADJUSTING THE SETTING OF THE VALVE. REPORTEDLY, THE SURGEON WAS ABLE TO DEPRESS THE DOME OF THE VALVE DURING THE SURGERY AND THE VALVE WAS FLOWING AND SEEMED TO BE FUNCTIONING. THE SURGEON IMPLANTED NEW VALVE IN A DIFFERENT LOCATION ON THE HEAD. 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 12790747 ↗