PROGAV 2.0 FX673TRecalls & reported problems

Aesculap AG · PROGAV 2.0 W/SA2.0 20 & PED.CONTROL RES. · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 7
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04041906502270), received between Jul 1, 2021 and Jul 6, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Infusion or Flow Problem4
Physical Resistance/Sticking2
Adverse Event Without Identified Device or Use Problem1
Mechanical Problem1
Obstruction of Flow1

Patient problems

Hydrocephalus7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

InjuryJul 6, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM(#FX673T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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 25716414 ↗
InjuryAug 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX673T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22773262 ↗
InjuryJul 10, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX673T) 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 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 22470994 ↗
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX673T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. NO PRODUCT PROBLEM OR PATIENT DATA WERE SUBMITTED BY THE COMPLAINANT, BUT 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 problems: Hydrocephalus
MAUDE report 19613719 ↗
InjuryMar 6, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX673T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. 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: 1 YEARS, 2 MONTHS, WEIGHT: 8.6 KGS, HEIGHT: 78 CM, GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 18848204 ↗
InjurySep 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX673T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE, IS BLOCKED AND WAS DIFFICULT TO ADJUST. 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: 4 YEARS, HEIGHT: 106 CENTIMETERS (CM), WEIGHT: 16 KILOGRAMS (KG). SAME EVENT ALS MEDWATCH-NO. 3004721439-2022-00279.
Patient problems: Hydrocephalus
MAUDE report 15464559 ↗
InjuryJul 1, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED TO MIETHKE THAT A PROGAV 2.0 SHUNTSYSTEM (PART # # FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE. 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: 120 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 12099498 ↗

Device details

UDI-DI	`04041906502270`
Brand	PROGAV 2.0
Model	FX673T
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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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