GAV 2.0Recalls & reported problems across all models
Aesculap AG · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 16 models of GAV 2.0 by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2020 and Aug 31, 2026 — classified as 52 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GAV 2.0 problems
Device problems
- Infusion or Flow Problem45
- Obstruction of Flow8
- Excess Flow or Over-Infusion1
- Insufficient Device Problem Information1
- Insufficient Flow or Under Infusion1
Patient problems
- Hydrocephalus50
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
GAV 2.0 models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GAV 2.0 FX215TShunt, central nervous system and components10 reports
- GAV 2.0 FX214TShunt, central nervous system and components9 reports
- GAV 2.0 FX153TShunt, central nervous system and components7 reports
- GAV 2.0 FX212TShunt, central nervous system and components6 reports
- GAV 2.0 FX210TShunt, central nervous system and components5 reports
- GAV 2.0 FX156TShunt, central nervous system and components3 reports
- GAV 2.0 FX211TShunt, central nervous system and components3 reports
- GAV 2.0 FX217TShunt, central nervous system and components2 reports
- GAV 2.0 FX230TShunt, central nervous system and components2 reports
- GAV 2.0 FX148TShunt, central nervous system and components2 reports
- GAV 2.0 FX280TShunt, central nervous system and components1 report
- GAV 2.0 FX216TShunt, central nervous system and components1 report
- GAV 2.0 FX221TShunt, central nervous system and components1 report
- GAV 2.0 FX272TShunt, central nervous system and components1 report
- GAV 2.0 FX231TShunt, central nervous system and components1 report
- GAV 2.0 FX266TShunt, central nervous system and components1 report
Recent GAV 2.0 adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryNov 6, 2025Infusion or Flow Problem; Infusion or Flow Problem
ACCORDING TO THE COMPLAINANT THE SURGEON HAD PREVIOUSLY IMPLANTED VALVE IN PATIENT AND SHUNT WAS NOT DRAINING AT A RATE SURGEON FELT WAS APPROPRIATE. REPORTEDLY THE PRESSURE SETTING WAS TOO HIGH FOR PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 23486109 ↗InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem
THE INVESTIGATION OF THE VALVE HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 23463427 ↗InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 (#FX215T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED DRAINAGE PROBLEM. DEEMED PRESSURE SETTING WAS TOO HIGH FOR PATIENT. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME PATIENT AS MEDWATCH# 3004721439-2025-00333.
Patient problems: Hydrocephalus
MAUDE report 23463426 ↗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 ↗InjuryJul 28, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV 2.0 VALVE (#FX266T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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 22628984 ↗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 ↗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 ↗InjuryFeb 18, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 (#FX211T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THEVALVE 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 21397209 ↗InjuryFeb 18, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A GAV 2.0 (#FX280T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2022. ACCORDING TO THE COMPLAINANT, THE VALVE 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 21392130 ↗InjuryOct 28, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A GAV 2.0 (#FX214T) 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) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 20546222 ↗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 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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