proGAV 2.0® FX352TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04041906140014), received between Oct 18, 2021 and Mar 9, 2026 — classified as 12 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem6
- Infusion or Flow Problem4
- Physical Resistance/Sticking4
- Obstruction of Flow2
- Microbial Contamination of Device1
Patient problems
- Hydrocephalus13
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 24547110 ↗MalfunctionMar 9, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX352T) WAS BLOCKED PRE-IMPLANTATION. NO PATIENT INVOLVEMENT. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus; No Clinical Signs, Symptoms or Conditions
MAUDE report 24547109 ↗InjurySep 10, 2025Microbial Contamination of Device; Microbial Contamination of Device
CUSTOMER REPORTEDA CASE OF INFECTION WITH A PERITONEAL CATHTER (#(B)(6)) NO PATIENT DATA AVAILABLE. NO PATIENT HARM REPORTED. SAME EVENT AS #3004721439-2025-00258, #3004721439-2025-00259.
Patient problems: Hydrocephalus
MAUDE report 23017739 ↗InjuryJun 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX352T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. 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 DEVICE WAS NOW RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22175004 ↗InjuryMay 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER AND THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 22030196 ↗InjuryApr 28, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX385T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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 21917138 ↗InjuryNov 9, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX352T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE AN ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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: 76 YEARS 11 MONTHS . WEIGHT: 40 KILOGRAMS. HEIGHT: 148 CENTIMETERS. GENDER: FEMALE. SAME EVENT AS # 3004721439-2023-00330, AND # 3004721439-2023-00331.
Patient problems: Hydrocephalus
MAUDE report 18104181 ↗InjuryAug 25, 2023Infusion or Flow Problem; Infusion or Flow Problem
THE RETURNED PRODUCT FOR INVESTIGATION IS A PROGAV 2.0 SHUNTSYSTEM (#FX352T). THE FOLLOW UP WAS UPDATED COMPLETELY. PATIENT DATA: AGE: 66 YEARS.
Patient problems: Hydrocephalus
MAUDE report 17625340 ↗InjuryJun 1, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX352T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 CAUSED AN SPONTANEOUS SETTING CHANGE. REPORTEDLY, THE PATIENT MAY HAVE MANIPULATED SETTING WITH MAGNETIC TOY. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 10 YEARS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 17043591 ↗InjuryMay 26, 2023Mechanical Problem; Mechanical Problem
InjuryJun 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 WITH SHUNTASSISTANT (#FX352T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. 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: 76 YEARS. HEIGHT: 170 CENTIMETERS (CM). WEIGHT: 80 KILOGRAMS (KG). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 14781565 ↗InjuryFeb 9, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX352T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN MALFUNCTION. 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. ASSOCIATED MEDWATCH REPORT # 3004721439-2022-00014 AND 3004721439-2022-00015.
Patient problems: Hydrocephalus
MAUDE report 13502097 ↗InjuryOct 18, 2021Mechanical Problem; Mechanical Problem
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
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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