ShuntAssistantRecalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls
- 0
We found 5 models of ShuntAssistant by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2020 and Apr 27, 2026 — classified as 47 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ShuntAssistant problems
Device problems
- Infusion or Flow Problem41
- Mechanical Problem4
- Adverse Event Without Identified Device or Use Problem2
- Material Deformation2
- Obstruction of Flow2
- Deformation Due to Compressive Stress1
- No Flow1
- Pressure Problem1
Patient problems
- Hydrocephalus47
- Intraoperative Pain1
- Needle Stick/Puncture1
- Skin Tears1
ShuntAssistant models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ShuntAssistant® FV251TShunt, central nervous system and components26 reports
- ShuntAssistant® FV252TShunt, central nervous system and components13 reports
- ShuntAssistant® FV250TShunt, central nervous system and components8 reports
- ShuntAssistant® FV253TShunt, central nervous system and components1 report
- ShuntAssistant® FV261TShunt, central nervous system and components1 report
Recent ShuntAssistant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN SHUNTASSISTANT 15 (#FV250T) WAS IMPLANTED TO REDUCE THE SIZE OF THE VENTRICLE. ACCORDING TO THE HOSPITAL, IT SEEMED LIKE THE SHUNTASSISTANT WAS WORKING TOO WELL. BEFORE THE OPERATION, IT WAS CONFIRMED THAT THE SHUNT WAS NOT BLOCKED. THE EXAMINATION IS BEING CONDUCTED AS A PRECAUTION.
Patient problems: Hydrocephalus
MAUDE report 25001893 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN SHUNTASSISTANT 15 (#FV250T) WAS IMPLANTED TO REDUCE THE SIZE OF THE VENTRICLE. ACCORDING TO THE HOSPITAL, IT SEEMED LIKE THE SHUNTASSISTANT WAS WORKING TOO WELL. THEREFORE, AN ADDITIONAL SURGERY WAS PERFORMED TO SWITCH THE SHUNTASSISTANT WITH A PRESSURE SETTING OF 10.
Patient problems: Hydrocephalus
MAUDE report 25001840 ↗InjuryJun 18, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNT ASSISTANT (#F251T) WAS IMPLANTED AND LATER COMBINED WIT ANOTHER PROGAV 2.0 SHUT SYSTEM ON AN UNSPECIFIED DATE. 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS PARTICULAR VALVE WAS SENT ADDITIONALLY TO RM (B)(4) CC400709572. PRIOR TO RECEIVING THE ORIGINALLY REPORTED SHUNT SYSTEM, WE HAD NO KNOWLEDGE OF THIS SHUNT ASSISTANT. RM (B)(4) CC400709572 IS REPORTED WITH MEDWATCH NO.: 3004721439-2025-00149.
Patient problems: Hydrocephalus
MAUDE report 22284332 ↗InjuryMar 31, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNT ASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT 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 21730372 ↗MalfunctionNov 18, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNT ASSISTANT (# FV252T) WAS TESTED PREOPERATIVELY AND SHOWED UNEXPECTED BEHAVIOR. NO PATIENT INVOLVEMENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.
Patient problems: Hydrocephalus
MAUDE report 20705008 ↗MalfunctionNov 18, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS TESTED PREOPERATIVELY AND SHOWED UNEXPECTED BEHAVIOR. NO PATIENT INVOLVEMENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.
Patient problems: Hydrocephalus
MAUDE report 20704986 ↗InjuryMay 1, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT(#FV251T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. 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: 5 MONTHS. HEIGHT: 56 CM. WEIGHT: 4.95 KG. GENDER: MALE. SAME EVENT AS MEDWATCH#3004721439-2024-00106 + MEDWATCH#3004721439-2024-00108.
Patient problems: Hydrocephalus
MAUDE report 19226188 ↗InjuryMar 6, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNT ASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 16 YEARS WEIGHT: 38 KGS HEIGHT: 153 CM GENDER: MALE SAME EVENT AS # 3004721439-2024-00055.
Patient problems: Hydrocephalus
MAUDE report 18848401 ↗InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS IMPLANTED COMBINED WITH A PROGAV 2.0 (#FX410T) AND A PROSA (#FV701T) DURING A PROCEDURE PERFORMED ON 11/24/2020. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. 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: 34 YEARS. HEIGHT: 160 CM. WEIGHT: 65 KG. GENDER: FEMALE. SAME EVENT AS MEDWATCH#3004721439-2023-00355 AND #3004721439-2023-00356.
Patient problems: Hydrocephalus
MAUDE report 18246931 ↗InjuryOct 4, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN 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: 10 YEARS, HEIGHT: 132 CENTIMETERS, WEIGHT: 25 KILORGRAMS, GENDER: MALE. SAME PATIENT/EVENT AS MEDWATCH NO.:3004721439-2023-00289.
Patient problems: Hydrocephalus
MAUDE report 17872611 ↗InjuryMay 11, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A BLOCKAGE THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 56 YEARS. SAME EVENT AS # 3004721439-2023-00122
Patient problems: Hydrocephalus
MAUDE report 16913330 ↗InjuryApr 3, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 9 YEARS. HEIGHT: 90 CENTIMETERS (CM). WEIGHT: 40 KILOGRAMS (KG). GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2023-00067.
Patient problems: Hydrocephalus
MAUDE report 16668655 ↗InjuryFeb 28, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE. 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: 18 YEARS. HEIGHT: 165 CENTIMETERS (CM). WEIGHT: 65 KILOGRAMS (KG). GENDER: MALE. SAME EVENT MEDWATCH MDR ID # 3004721439-2023-00031.
Patient problems: Hydrocephalus
MAUDE report 16452967 ↗InjuryJan 20, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND NON-ADJUSTABILITY. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2022. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS (B)(4)/ 3004721439-2022-00428.
Patient problems: Hydrocephalus
MAUDE report 16219209 ↗InjuryJan 18, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND NON-ADJUSTABILITY. 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: 6 YEARS, HEIGHT: 120 CENTIMETERS (CM), WEIGHT: 15 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS: #3004721439-2022-00418.
Patient problems: Hydrocephalus
MAUDE report 16199860 ↗
Other Christoph Miethke GmbH & Co. KG products
All Christoph Miethke GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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