GAV 2.0 FX153TRecalls & reported problems

Aesculap AG · GAV 2.0 SYS W/PED.CONTROL RESERV.5/25 · 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 04041906142926), received between Apr 17, 2024 and Apr 7, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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

Obstruction of Flow4
Infusion or Flow Problem3

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.

InjuryApr 7, 2026Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 SHUNT SYSTEM (#FX153T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24802354 ↗
InjuryNov 25, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 (#FX153T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 23643766 ↗
InjuryNov 24, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 (# FX153T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 23631320 ↗
InjuryMay 2, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PED. CONTROL RESERVOIR (PART OF FX153T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE RESERVOIR CAUSED UNDERDRAINAGE. THE RESERVOIR WAS REVISED ON (B)(6) 2024. NO COMPLICATIONS WERE REPORTED IN THE PATIENT AS A RESULT OF THE REVISION PROCEDURE. THE PRODUCT IN QUESTION WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21949354 ↗
InjurySep 27, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 SHUNT SYSTEM (#FX153T) 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: 6 MONTHS; WEIGHT: 4.9 KGS; HEIGHT: 57 CM; GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20320759 ↗
InjuryJul 1, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 (#FX153T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 3 MONTHS. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 19644904 ↗
InjuryApr 17, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 WITH PEDI. PRECHAMBER (#FX153T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. 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: UNKNOWN. HEIGHT: UNKNOWN. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19127786 ↗

Device details

UDI-DI	`04041906142926`
Brand	GAV 2.0
Model	FX153T
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	Feb 3, 2022

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.

Other Shunt, central nervous system and components devices

NATUS EDS3 DRAINAGE SYSTEM NT821731C
Natus Medical Incorporated · Shunt, Central Nervous System And Components
1 recall208 reports
Exacta™ 46700
Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
1 recall2 deaths163 reports
Strata® 42866
Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
1 death160 reports
proGAV 2.0® FX410T
Christoph Miethke GmbH & Co. KG · Shunt, central nervous system and components
119 reports
PROGAV 2.0 FX643T
Aesculap AG · Shunt, central nervous system and components
100 reports
Becker® 46128
Medtronic Ps Medical, Inc. · Shunt, central nervous system and components
1 recall50 reports
M.BLUE PLUS FX804T
Aesculap AG · Shunt, central nervous system and components
82 reports
proSA® FV701T
Christoph Miethke GmbH & Co. KG · Shunt, central nervous system and components
82 reports

All Shunt, central nervous system and components devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page