proGAV 2.0® FX438TRecalls & reported problems

Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS PED.WITH PRECHAMBER · Class 2 · Implant

All models of proGAV 2.0 (49)

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

Adverse event reports: 8
Deaths reported: 0
Injuries reported: 8
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906137434), received between Feb 2, 2018 and Oct 20, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 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 Problem6
Physical Resistance/Sticking3
Mechanical Problem2
Insufficient Device Problem Information1
Obstruction of Flow1
Partial Blockage1

Patient problems

Hydrocephalus8
No Known Impact Or Consequence To Patient1
Obstruction/Occlusion1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

InjuryOct 20, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER AND THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 23335443 ↗
InjuryAug 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 (#FX438T) WAS IMPLANTED TOGETHER WITH AN SHUNTASSISTANT (FV413-T) DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCTS WERE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME INCIDENT AS MEDWATCH #3004721439-2025-00220.
Patient problems: Hydrocephalus
MAUDE report 22698255 ↗
InjuryMay 1, 2025Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking; Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX438T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT PROBLEMS. 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 NOW SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21941692 ↗
InjuryApr 28, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX438T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 2 YEARS, 7 MONTHS. WEIGHT: 14 KILOGRAMS (KG). HEIGHT: 93.5 CENTIMETERS (CM). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16838793 ↗
InjuryJul 14, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX438T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. 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: 3 YEARS. GENDER: FEMALE. SAME EVENT AS MEDWATCH#3004721439-2022-00200.
Patient problems: Hydrocephalus
MAUDE report 15020903 ↗
InjuryNov 16, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX438T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN OVER AND UNDERDRAINAGE AND WAS NOT ADJUSTABLE. 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) YEARS, HEIGHT: 180 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: MALE. ITS THE SAME PATIENT AS # 3004721439-2021-00309.
Patient problems: Hydrocephalus
MAUDE report 12823995 ↗
InjuryMar 30, 2021Infusion or Flow Problem; Infusion or Flow Problem
ADDITIONAL INFOFMATION: AGE: 15 MONTHS HEIGHT: 58 CM WEIGHT: 5.3 KG.
Patient problems: Hydrocephalus; Obstruction/Occlusion
MAUDE report 11589357 ↗
InjuryFeb 2, 2018Partial Blockage; Infusion or Flow Problem; Partial Blockage; Infusion or Flow Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THERE IS BLOCKAGE IN THE VALVE.
Patient problems: Hydrocephalus; No Known Impact Or Consequence To Patient
MAUDE report 7236118 ↗

Device details

UDI-DI	`04041906137434`
Brand	proGAV 2.0®
Model	FX438T
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	In Commercial Distribution
Record updated	Apr 7, 2021

Device type (GMDN): Ventriculo-peritoneal/atrial shunt

An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. Disposable devices associated with implantation may be included.

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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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