miniNAVRecalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 7 models of miniNAV by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2020 and Sep 28, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (14 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 miniNAV problems
Device problems
- Infusion or Flow Problem14
- Obstruction of Flow3
- Excess Flow or Over-Infusion2
- Insufficient Device Problem Information1
- Mechanical Problem1
- Reflux within Device1
Patient problems
- Hydrocephalus18
- Failure of Implant2
miniNAV models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- miniNAV® FV660TShunt, central nervous system and components11 reports
- miniNAV® FV667TShunt, central nervous system and components2 reports
- miniNAV® FV679TShunt, central nervous system and components2 reports
- miniNAV® FV683TShunt, central nervous system and components2 reports
- miniNAV® FV680TShunt, central nervous system and components1 report
- miniNAV® FV684TShunt, central nervous system and components1 report
- miniNAV® FV672TShunt, central nervous system and components1 report
Recent miniNAV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Infusion or Flow Problem
On(b)(6)2026 MIETHKE received the information about a complaint regarding a miniNAV from C.H.U. de Toulouse.The hospital reported that the implanted valve showed drainage problems. The patient underwent a revision procedure on August 04, 2026. No patient complications were reported as a result of the revision procedure. The device is not available for examination.
Patient problems: Hydrocephalus
MAUDE report 50913373 ↗InjurySep 28, 2026Infusion or Flow Problem
On September 04, 2026 MIETHKE received the information about a complaint regarding a miniNAV from C.H.U. de Toulouse.The hospital reported that the implanted 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. The device is not available for examination.
Patient problems: Hydrocephalus
MAUDE report 50913266 ↗InjuryNov 24, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
IT WAS REPORTED THAT A MINNAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE WAS REVISED, DUE TO A FLOW BACK. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 23631288 ↗InjuryNov 24, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV (FV683T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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 23631082 ↗InjuryNov 17, 2025Reflux within Device; Reflux within Device
ACCORDING TO THE COMPLAINANT A MININAV VALVE 10 "PART#: FV660T" WAS IMPLANTED ON AN UNSPECIFIED DATE. REPORTEDLY THE VALVE WAS TAKEN OUT OF THE PATIENT BECAUSE "THE ARROW WAS POINTED DISTALLY."
Patient problems: Failure of Implant
MAUDE report 23573193 ↗InjuryFeb 18, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED TO AESCULAP INC. THAT A MININAV VALVE 10 (PART# FV660T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THERE WAS A SHUNT MALFUNCTION RESULTING IN A SHUNT REVISION. UPON TESTING OF THE MINI NAV (FLUSH WITH NACL) THE FLUID DID NOT PASS THROUGH MINI NAV. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4).
Patient problems: Failure of Implant
MAUDE report 21397811 ↗InjuryFeb 13, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A MINIVAV VALVE 10 (#FV660T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE / BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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 21373906 ↗InjuryOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A MININAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 10 MONTHS. HEIGHT: 50 CM. WEIGHT: 6 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20424032 ↗InjuryOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A MININAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 9 MONTHS, HEIGHT: 65 CM, WEIGHT: 7 KG, GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20422262 ↗InjuryAug 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV SET WITH PAEDIATRIC PRECHAMBER (#FV679T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PAEDIATRIC PRECHAMBER HAD A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE PRECHAMBER WAS EXCHANGED AND THE VALVE IS STILL IMPLANTED AND FUNCTIONING. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 MONTHS. HEIGHT: 63 CM. WEIGHT: 6,3 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20048626 ↗InjuryAug 22, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV (#FV684T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. 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: 9 MONTHS. HEIGHT: 60 CM. WEIGHT: 5 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20030746 ↗InjuryMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV WITH SPRUNG RESERVOIR WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-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: 7 YEARS. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19335285 ↗InjuryAug 9, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. 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: 8 MONTHS, WEIGHT: 5.5 KILOGRAMS (KG), HEIGHT: 63 CENTIMETERS (CM), GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 17494366 ↗InjuryJan 20, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV (PART # FV679T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE. 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: 2 MONTHS. HEIGHT: 48 CENTIMETERS (CM). WEIGHT: 3.8 KILOGRAMS (KG). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16219059 ↗InjuryOct 5, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A MININAV(PART # FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN COMBINATION WITH A PROGAV 2.0 AND A M.BLUE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT 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: 6 YEARS, HEIGHT: 136 CENTIMETERS (CM), WEIGHT: 38 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH # 3004721439-2022-00303.
Patient problems: Hydrocephalus
MAUDE report 15547103 ↗
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.
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