proGAV 2.0® FX418TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SA10 AND DISTAL CATHETER · Class 2 · Implant
All models of proGAV 2.0 (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04041906136604), received between Jul 27, 2021 and Dec 23, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Mechanical Problem2
- No Flow1
Patient problems
- Hydrocephalus4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2025No Flow; No Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX418T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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.
Patient problems: Hydrocephalus
MAUDE report 23876315 ↗InjuryMay 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX418T) WAS IMPLANTED DURING A REVISION PROCEDURE (MEDWATCH# 3004721439-2024-00120) PERFORMED ON (B)(6) 2024. THE SHUNT SYSTEM WAS IMPLANTED TOGETHER WITH A SPRUNG RESERVOIR SET #FV046T (MEDWATCH # 3004721439-2024-00153). ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT AN ADDITIONAL 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: 7 MONTHS HEIGHT: 64 CM WEIGHT: 9 KG GENDER: MALE SAME INCIDENT/PATIENT AS MEDWATCH# 3004721439-2024-00153.
Patient problems: Hydrocephalus
MAUDE report 19405017 ↗InjuryMay 16, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (# FX418T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 COULD NOT BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT'S DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED OF AT THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT DATA ARE KNOWN. SAME EVENT AS # 3004721439-2024-00119.
Patient problems: Hydrocephalus
MAUDE report 19335118 ↗InjuryJul 27, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX418T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE AND TO HAVE A PROBLEM WITH THE ADJUSTABILITY. 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. AGE: (B)(6) YEAR, HEIGHT: (B)(6), WEIGHT: (B)(6), GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 12233144 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page