proGAV 2.0® FX490TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906137786), received between Nov 11, 2021 and Apr 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Obstruction of Flow

  ACCORDING TO THE EVENT DESCRIPTION: PATIENT HAD SEVERAL ED VISITS IN A 3-WEEK PERIOD FOR EPISODIC VOMITING, SOMNOLENCE, AND FULL/TENSE SUBGALEAL COLLECTION DUE TO SHUNT MALFUNCTION (WITH ENLARGED VENTRICLES). CONDITION IMPORVED TEMPORARILY TO SHUNT ADJUSTMENT. INTRA-OP FOUND TO HAVE VERY LITTLE FLOW THROUGH THE VALVE. THIS REPORT IS FILED UNDER AIC REFERENCE XC (B)(4) CC (B)(4)

  Patient problems: Hydrocephalus; Sleepiness/Drowsiness/Somnolence; Vomiting

  MAUDE report 25048696 ↗
• InjuryMar 30, 2026Obstruction of Flow; Calibration Problem

  ACCORDING TO THE EVENT DESCRIPTION: URGENT SHUNT REVISION ON A 11 MONTH OLD MALE. THE VALVE SEEMED TO HAVE FLOW FOLLOWING EXPLANT BUT REQUIRED MANY OUTPATIENT ADJUSTMENTS. THE CLINICAL TEAM IS SUSPECTING OCCLUSION OR FAULTY MECHANISM AND REQUESTING ANALYSIS POST EXPLANT TO CONFIRM.

  Patient problems: Hydrocephalus

  MAUDE report 24715616 ↗
• InjuryMar 30, 2026Separation Problem

  ACCORDING TO THE EVENT DESCRIPTION: PROGAV VALVE MR BREAK DOESN'T SEEM TO BE WORKING APPROPRIATELY. IT FEELS LIKE IT IS STICKING AND NOT AS SMOOTH AS IT USUALLY IS. THIS IS MAKING IT CHALLENGING TO REPROGRAM THE VALVE. VALVE IS BEING EXPLANTED AND REVISED.

  Patient problems: Hydrocephalus

  MAUDE report 24714764 ↗
• InjuryJan 3, 2025Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX490T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, AT THE PATIENT'S FOLLOW-UP CHECKUP ON (B)(6) 2024, THE CLINICAL CONSULTANT HAD TROUBLE REPROGRAMMING THE VALVE, INITIALLY SET TO ZERO (0) CENTIMETERS (CM) H20. THE VALVE WAS EVENTUALLY ADJUSTED TO ONE (1) CM H20. HOWEVER, ON (B)(6) 2024, THE SURGEON REPORTED THAT THE PATIENT WAS EXPERIENCING HYDROCEPHALUS SYMPTOMS CONSISTENT WITH UNDERDRAINAGE. FURTHER EXAMINATION REVEALED A KINK IN THE PERITONEAL CATHETER. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINT PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 21072436 ↗
• InjuryDec 31, 2024Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX490T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. SHUNT SYSTEM REVEALED THAT THERE WAS A KINK IN PERITONEAL CATHETER. 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 21047907 ↗
• InjuryMay 2, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR (PRODUCT # FX490T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE VALVE WAS DISCOVERED TO BE OCCLUDED ON (B)(6) 2023. THE PAITENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023 IN ORDER TO REPLACE THE CLOGGED VALVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 16857193 ↗
• InjuryMay 2, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX490T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS FOUND TO BE OCCLUDED ON (B)(6) 2023. THE PAITENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE COMPLAINT 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 16856614 ↗
• InjuryNov 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV 2.0 WITH PED. BURRHOLE RESERVOIR (PART # FX490T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS NOT WORKING PROPERLY WHEN PUT TOGETHER AND INLINE, BUT EACH COMPONENT (RESERVOIR, VALVE, & SHUNT ASSIST) SEEMED TO WORK INDIVIDUALLY. THE SURGEON TOOK OUT THE VALVE SYSTEM AND REPLACED IT WITH ALL NEW COMPONENTS OF THE SAME PRODUCT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hydrocephalus

  MAUDE report 12795260 ↗