PROGAV 2.0 FX385TRecalls & reported problems

Aesculap AG · PROGAV 2.0 W/SA2.0 20 & SPRUNG RESERVOIR · Class 2 · Implant

All models of PROGAV 2.0 (43)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04041906502461), received between Feb 28, 2023 and Jun 15, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Calibration Problem” (1 report).

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

Calibration Problem1
Infusion or Flow Problem1
Mechanical Problem1
Obstruction of Flow1
Physical Resistance/Sticking1

Patient problems

Hydrocephalus3
Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryJun 15, 2026Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX385T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 VALVE HAD UNINTENDED SHUNT ADJUSTMENT. 4 YEARS AGO, THE PATIENT HAVE A PREVIOUSLY SELF- ADJUSTED VALVE, TOO. THE NEUROSURGEON SUSPECTED THAT THE PATIENT ADJUSTED THE SHUNT HIMSELF. THE PATIENT UNDERWENT A REVISION PROCEDURE AND A NEW SINGLE PRESSURE VALVE WAS IMPLANTED. THE SHUNT IS STILL IN TRANSIT TO MANUFACTURER FOR EXAMINATION.
Patient problems: Hydrocephalus
MAUDE report 25505506 ↗
InjuryFeb 19, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21410548 ↗
InjuryMar 8, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX385T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWO (2) DAYS AFTER BEING IMPLANTED, THE VALVE SETTING WAS NOT ABLE TO BE REPROGRAMMED. THE SURGEON MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO PERFORM THE ADJUSTMENT WITH THE SALES REPRESENTATIVE PRESENT. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 16507353 ↗
InjuryFeb 28, 2023Calibration Problem; Calibration Problem
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 W/SA2.0 20 & SPRUNG RESERVOIR (PART # FX385T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWO (2) DAYS AFTER BEING IMPLANTED, THE VALVE SETTING WAS NOT ABLE TO BE REPROGRAMMED. THE SURGEON MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO PERFORM THE ADJUSTMENT WITH THE SALES REPRESENTATIVE PRESENT. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 16453360 ↗

Device details

UDI-DI	`04041906502461`
Brand	PROGAV 2.0
Model	FX385T
Company	Aesculap AG
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	Labeling does not contain MRI Safety Information
Status	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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