proGAV® FV414TRecalls & reported problems

Christoph Miethke GmbH & Co. KG · PROGAV WITH SHUNTASSISTANT 25 · Class 2 · Implant

All models of proGAV (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Miethke proGAV shunt is a cerebrospinal fluid shunt implant. Most of the 77 adverse event reports describe drainage problems — underdrainage or overdrainage — that led to revision surgery, with some also mentioning infection and adjustment difficulties. There are no deaths, but 77 injuries. No recalls name this device, and reports naming it fell from 12 to 5 over the past 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 77
Deaths reported: 0
Injuries reported: 77
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04041906132118), received between Dec 5, 2017 and May 19, 2026 — classified as 77 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (64 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Infusion or Flow Problem64
Mechanical Problem42
Obstruction of Flow7
Physical Resistance/Sticking6
Microbial Contamination of Device1
Partial Blockage1

Patient problems

Hydrocephalus77
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

InjuryMay 19, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25214824 ↗
InjuryApr 20, 2026Microbial Contamination of Device
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, AN INFECTION WAS DIAGNOSED. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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 24927768 ↗
InjuryFeb 10, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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 24303698 ↗
InjuryDec 15, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV WIT SHUNTASSISTANT (30) (#FV415T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 23804682 ↗
InjuryNov 3, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (# FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND 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 SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23450866 ↗
InjuryOct 20, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. 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 23336017 ↗
InjuryJul 11, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS # 3004721439-2025-00189.
Patient problems: Hydrocephalus
MAUDE report 22478040 ↗
InjuryJul 3, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22394322 ↗
InjuryMay 1, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. 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 21942043 ↗
InjuryMar 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THE PACKAGE WAS ONLY DELIVERED TO US TODAY BECAUSE IT WAS LOST IN THE MAIL. NOW IT HAS BEEN FOUND AND DELIVERED TO US. SAME EVENT AS #3004721439-2025-00069.
Patient problems: Hydrocephalus
MAUDE report 21558840 ↗
InjuryFeb 24, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 21447982 ↗
InjuryFeb 24, 2025Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. 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 21447485 ↗
InjuryDec 30, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 21034734 ↗
InjuryDec 30, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 21034528 ↗
InjuryDec 9, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414TT) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 20877894 ↗
InjuryDec 4, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (#FV414TT) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6)2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS MED.WATCH NO.: 3004721439-2024-00367.
Patient problems: Hydrocephalus
MAUDE report 20849280 ↗
InjuryNov 18, 2024Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 20707219 ↗
InjurySep 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) 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 COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 4 YEARS 8 MONTHS HEIGHT: 93 CM WEIGHT: 12,9 KG GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20320794 ↗
InjurySep 18, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. 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: 19 YEARS. HEIGHT: 151 CM. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20245577 ↗
InjuryJul 24, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (#FX414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE 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: 3 YEARS. HEIGHT: 76 CM. WEIGHT: 9,5 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19818797 ↗
InjuryJul 17, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED 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: 8 MONTHS, WEIGHT: 9.24 KG, HEIGHT: 70CM, GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19760396 ↗
InjuryMay 17, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 6 YEARS, 6 MONTHS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19340007 ↗
InjuryMay 17, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE 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: 5 MONTHS GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19339996 ↗
InjuryApr 24, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 4 YEARS, 7 MONTHS. WEIGHT: 19 KGS. HEIGHT: 108 CM. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19175979 ↗
InjuryApr 17, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM 25 (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BLOCKED 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. PATIENT INFORMATION: AGE: 2 YEARS 7 MONTHS, WEIGHT: 13 KG, HEIGHT: 90 CM, GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19127974 ↗

Device details

UDI-DI	`04041906132118`
Brand	proGAV®
Model	FV414T
Company	Christoph Miethke GmbH & Co. KG
Product code	JXG · Shunt, central nervous system and components
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	Not in Commercial Distribution
Record updated	Apr 7, 2021

Device type (GMDN): Cerebrospinal fluid shunt valve

An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

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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 14, 2026 · each report above links to its original FDA record
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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