PaediGAVRecalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 15 models of PaediGAV by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2021 and May 18, 2026 — classified as 31 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (24 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 PaediGAV problems
Device problems
- Infusion or Flow Problem24
- Mechanical Problem5
- Obstruction of Flow4
- Break1
- Calcified1
- Insufficient Device Problem Information1
- Material Rupture1
Patient problems
- Hydrocephalus34
- No Clinical Signs, Symptoms or Conditions1
PaediGAV models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PaediGAV® FV288TShunt, central nervous system and components5 reports
- PaediGAV® FV295TShunt, central nervous system and components5 reports
- PaediGAV® FV294TShunt, central nervous system and components4 reports
- PaediGAV® FV304TShunt, central nervous system and components4 reports
- PaediGAV® FV286TShunt, central nervous system and components3 reports
- PaediGAV® FV272TShunt, central nervous system and components2 reports
- PaediGAV® FV284TShunt, central nervous system and components2 reports
- PaediGAV® FV301TShunt, central nervous system and components2 reports
- PaediGAV® FV303TShunt, central nervous system and components2 reports
- PaediGAV® FV273TShunt, central nervous system and components1 report
- PaediGAV® FV274TShunt, central nervous system and components1 report
- PaediGAV® FV278TShunt, central nervous system and components1 report
- PaediGAV® FV283TShunt, central nervous system and components1 report
- PaediGAV® FV287TShunt, central nervous system and components1 report
- PaediGAV® FV306TShunt, central nervous system and components1 report
Recent PaediGAV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIESA VALVE (#FV288T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS #: 3004721439-2026-00141.
Patient problems: Hydrocephalus
MAUDE report 25200135 ↗MalfunctionJan 20, 2026Obstruction of Flow
THE SAMPLES WAS NOW RETURNED TO MANUFACTURER FOR EXAMINATION. ARTICLE # (B)(4) WAS REPORTED IN MEDWATCH 3004721439-2026-00003.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114711 ↗InjuryApr 28, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PEDIGAV (#FV286T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE 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 21917140 ↗InjuryFeb 24, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PAEDIGAV VALVE 9/24 (#FV294T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE. 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 21448167 ↗InjuryFeb 10, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
IT WAS REPORTED THAT A PAEDIGAV VALVE (#FV278T) WAS IMPLANTED AND EXPLANTED. SO FAR, WE HAVE NO INFORMATION ABOUT THE REASON FOR THE EXPLANT. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 21348363 ↗InjuryJun 10, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV294T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 21 YEARS HEIGHT: 165 CM WEIGHT: 65 KG GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19498454 ↗InjuryMay 24, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV294T) WAS IMPLANTED. 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. THE RELEASE FOR INVESTIGATION IS MISSING AT THE TIME OF REPORTING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 20 YEARS HEIGHT: 170 CM WEIGHT: 55 KG GENDER: MALE
Patient problems: Hydrocephalus
MAUDE report 19393801 ↗MalfunctionApr 17, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE VALVE (#FV306T) WAS NOT DRAINING BEFORE USE, SO ANOTHER VALVE WAS USED TO PERFORM THE OPERATION. THE VALVE WAS SENT DRY IN NE SEALED STERILE PACKAGING TO THE MANUFACTURER FOR EXAMINATION.
Patient problems: Hydrocephalus
MAUDE report 19126915 ↗InjuryFeb 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022 . 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: 23 MONTHS. HEIGHT: 81.5 CM. WEIGHT: 8.3 KG. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 18771807 ↗InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV303T) WAS IMPLANTED TOGETHER WITH AN PROGAV 2.0 DURING A PROCEDURE PERFORMED IN (B)(6) 2021. 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: 68 YEARS. GENDER: FEMALE. SAME EVENT/PATIENT AS MEDWATCH#3004721439-2023-00367.
Patient problems: Hydrocephalus
MAUDE report 18249700 ↗InjurySep 6, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV 2.0 (#FV294T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2013. 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: 14 YEARS HEIGHT: 150 CENTIMETERS. WEIGHT: 48 KILOGRAMS. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 17691456 ↗MalfunctionJul 20, 2023Material Rupture; Material Rupture
NO SAMPLE RETURNED FOR ANALYSIS. THE CASE IS CLOSED WITH THE RECORDING OF THE PRODUCTION DATA.
Patient problems: Hydrocephalus
MAUDE report 17357602 ↗InjuryApr 6, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 7 YEARS, 1 MONTH. WEIGHT: 22 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16694339 ↗InjuryMar 2, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (PART # FV301T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2016. 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.
Patient problems: Hydrocephalus
MAUDE report 16474573 ↗InjuryJan 27, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV288T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE IN COMBINATION WITH A PROGAV 2.0 WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. 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: 17 YEARS, HEIGHT: 153 CENTIMETERS (CM), WEIGHT: 57 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH#3004721439-2022-00435 AND 3004721439-2022-00436.
Patient problems: Hydrocephalus
MAUDE report 16258210 ↗
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