GAV 2.0 FX212TRecalls & reported problems
Aesculap AG · GAV 2.0 VALVE 5/30 · Class 2 · Implant
All models of GAV 2.0 (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906500023), received between Oct 4, 2023 and Aug 31, 2026 — classified as 3 injuries, 3 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem4
- Obstruction of Flow2
- Insufficient Device Problem Information1
Patient problems
- Hydrocephalus5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Obstruction of Flow
It was reported that a GAV 2.0 (#FX212T) was implanted on (b)(6) 2026. According to the complainant, the valve caused an underdrainage. The patient underwent a revision procedure on (b)(6) 2026. The sample was returned for examination.
Patient problems: Hydrocephalus
MAUDE report 50515559 ↗InjuryOct 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 (#FX212T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON 09/09/2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 23390831 ↗MalfunctionApr 21, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AN GAV 2.0 SHUNTSYSTEM (#FX212T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025 . ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED PROBLEMS IN THE PREOPERATIVE TESTING AND WASN'T USED. NO PATIENT INVOLVEMENT OR HARM WSA REPORTED. THE COMPLAINED DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 21873651 ↗MalfunctionAug 7, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 (#) WAS TESTED PREOPERATIVELY AND DID NOT HAVE THE CORRECT PRESSURE LEVEL, THE VALVE WAS UNDERDRAINED. NO PATIENT INVOLVEMENT.
Patient problems: Hydrocephalus
MAUDE report 19930468 ↗MalfunctionMar 4, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT ONE OF THE GAV 2.0 (#FX212T) DIDN'T WORK PROPERLY AS IT IS FAULTY. AT PRE-IMPLANTATION CHECK NO FLOW THROUGH VALVE. THEN AFTER FLUSHING FLOW BUT AT MEASURE 15CM H2O AS OPPOSED TO 5CM H2O. THE VALVE WAS NOT IMPLANTED AND A DIFFERNET WAS USED AND FUNCTIONED NORMALLY. NO PATIENT HARM WAS REPORTED. THE SAMPLE WILL BE RETURNED FOR EVALUATION TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18829375 ↗InjuryOct 4, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 (#FX212T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN 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: 2 YEARS. WEIGHT: 12 KILOGRAMS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 17871889 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page