PROGAV 2.0 FX649TRecalls & reported problems
Aesculap AG · PROGAV 2.0 W/SA2.0 25 & DISTAL CATHETER · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04041906502072), received between Mar 10, 2021 and Oct 27, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (13 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
- Infusion or Flow Problem13
- Mechanical Problem6
- Obstruction of Flow5
- Physical Resistance/Sticking3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hydrocephalus19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. 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 23393368 ↗InjurySep 5, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22976892 ↗InjuryJul 21, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22554016 ↗InjuryMar 21, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 WAS IMPLANTED DURING ON (B)(6) 2020. ACCORDING TO THE PATIENT, THE VALVE HAD ADJUSTMENT DIFFICULTIES. A REVISION PROCEDURE WAS CARRIED OUT ON (B)(6) 2025. 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 21662338 ↗InjuryMar 17, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED IN (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. 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 21618183 ↗InjuryMay 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 2 YEARS. HEIGHT: 77 CM. WEIGHT: 9.2 KG. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19404784 ↗InjuryMay 16, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 46 YEARS. HEIGHT: 180 CM. WEIGHT: 110 KG.
Patient problems: Hydrocephalus
MAUDE report 19336869 ↗InjuryNov 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE. 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: 74 YEARS . WEIGHT: 100 KILOGRAMS. HEIGHT: 180 CENTIMETERS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 18049532 ↗InjuryAug 30, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS . WEIGHT: 15 KILOGRAMS. HEIGHT: 100 CENTIMETERS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 17650680 ↗InjuryJul 28, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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, 6 MONTHS HEIGHT: 85 CENTIMETERS (CM). WEIGHT: 13 KILOGRAMS (KG).
Patient problems: Hydrocephalus
MAUDE report 17420311 ↗InjuryMay 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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. AGE: 42 YEARS, HEIGHT: 168 CENTIMETERS (CM), WEIGHT: 74 KILOGRAMS (KG), GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 16855920 ↗InjuryApr 19, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. 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) 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: ~ 65 YEARS. HEIGHT: ~ 160 CENTIMETERS (CM). WEIGHT: ~ 60 KILOGRAMS (KG) .GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 16773380 ↗InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART OF SHUNTSYSTEM #FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON NOVEMBER (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: 5 YEARS, HEIGHT: 100 CENTIMETERS (CM), WEIGHT: 15 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT/PATIENT AS MEDWATCH # 3004721439-2022-00367.
Patient problems: Hydrocephalus
MAUDE report 15936725 ↗InjuryNov 22, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 26 YEARS. HEIGHT: 164 CENTIMETERS (CM). WEIGHT: 68 KILOGRAMS (KG). GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 15848264 ↗InjuryMay 26, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYTSEM (PART # FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2021. 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: 2 YEARS. HEIGHT: 100 CENTIMETERS (CM). WEIGHT: 13 KILOGRAMS (KG). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 14519594 ↗InjuryFeb 16, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE UNDERDRAINED AND WAS UNABLE TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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), GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 13546219 ↗InjuryJul 13, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX649T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRIANAGE. 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: UNKNOWN WEIGHT: UNKNOWN GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 12158886 ↗InjuryApr 15, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM ((B)(4) ) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNTSYSTEM WAS BELIEVED TO BE OPERATED IN OVER- DRAINAGE. THE VENTRICLE ARE NARROWED. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATION: (B)(6). GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 11671467 ↗InjuryMar 10, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS A FLOW PROBLEM OF A PROGAV 2.0 SHUNTSYSTEM. PATIENT INFORMATION: AGE: (B)(6). WEIGHT: (B)(6), HEIGHT: 180 CM, GENDER: MALE, DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REMOVAL: (B)(6) 2021.
Patient problems: Hydrocephalus
MAUDE report 11454544 ↗
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- 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
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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.
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