SHUNTASSISTANT 2.0Recalls & reported problems across all models
Aesculap AG · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 0
We found 6 models of SHUNTASSISTANT 2.0 by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2021 and Jun 8, 2026 — classified as 35 injuries, 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (27 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 SHUNTASSISTANT 2.0 problems
Device problems
- Infusion or Flow Problem27
- Obstruction of Flow7
- Adverse Event Without Identified Device or Use Problem1
- Calibration Problem1
Patient problems
- Hydrocephalus35
- No Clinical Signs, Symptoms or Conditions1
SHUNTASSISTANT 2.0 models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SHUNTASSISTANT 2.0 FX103TShunt, central nervous system and components19 reports
- SHUNTASSISTANT 2.0 FX102TShunt, central nervous system and components11 reports
- SHUNTASSISTANT 2.0 FX101TShunt, central nervous system and components2 reports
- SHUNTASSISTANT 2.0 FX105TShunt, central nervous system and components2 reports
- SHUNTASSISTANT 2.0 FX100TShunt, central nervous system and components1 report
- SHUNTASSISTANT 2.0 FX104TShunt, central nervous system and components1 report
Recent SHUNTASSISTANT 2.0 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. RELATED TO RM 5995 - CC400760246 / MED.WATCHNO.: 3004721439-2026-00152
Patient problems: Hydrocephalus
MAUDE report 25430535 ↗InjuryMay 18, 2026Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT 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. SAME EVENT AS #: 3004721439-2026-00134.
Patient problems: Hydrocephalus
MAUDE report 25200066 ↗InjuryMar 9, 2026Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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. SAME EVENT AS # 3004721439-2026-00055.
Patient problems: Hydrocephalus
MAUDE report 24546401 ↗InjuryDec 1, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (25) (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 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. SAME EVENT/PATIENT AS #3004721439-2025-00354
Patient problems: Hydrocephalus
MAUDE report 23679754 ↗InjurySep 15, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 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. SAME EVENT AS #3004721439-2025-00267.
Patient problems: Hydrocephalus
MAUDE report 23051395 ↗InjuryAug 4, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX102T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22698084 ↗InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO DEVICE WAS RETURNED TO THE MANUFACTURER SAME INCIDENT AS MEDWATCH#3004721439-2025-00161.
Patient problems: Hydrocephalus
MAUDE report 22411188 ↗InjuryJul 2, 2025Calibration Problem; Calibration Problem
ACCORDING TO THE EVENT DESCRIPTION THE VALVE IS NOT CLICKING OR ABLE TO BE REPROGRAMMED. REPORTEDLY THE VALVE WAS ADJUSTED TO SETTING THAT THE PATIENT NEEDED BEFORE IMPLANTING IT. THE VALVE WORKED FINE WHEN IT WAS IN THE PACKAGING BUT NOW THAT IT IS IMPLANTED IN THE PATIENT IT WON'T CLICK AND THEREFORE, UNABLE TO BE REPROGRAMMED. REPORTEDLY THE PATIENT WILL UNDERGO A REVISION PROCEDURE BUT HAS YET TO BE SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382138 ↗InjuryApr 21, 2025Obstruction of Flow; Obstruction of Flow
THE RELEASE FOR EXAMINATION HAS NOW BEEN SUBMITTED AND THE INVESTIGATION COULD BE CARRIED OUT. SAME INCIDENT AS MEDWATCH# 3004721439-2025-00106 AND #3004721439-2025-00107.
Patient problems: Hydrocephalus
MAUDE report 21873231 ↗InjuryJan 15, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6)2024. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME INCIDENT AS MEDWATCH#3004721439-2024-00423.
Patient problems: Hydrocephalus
MAUDE report 21157270 ↗InjuryDec 4, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX102T) WAS IMPLANTED ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. 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. SAME EVENT AS MED. WATCH NO: 3004721439-2024-00366.
Patient problems: Hydrocephalus
MAUDE report 20846861 ↗InjuryAug 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FX101T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 59 YEARS. HEIGHT: 175 CM. WEIGHT: 92 KG. GENDER: MALE. SAME PATIENT/ EVENT AS MED-WATCH NO.
Patient problems: Hydrocephalus
MAUDE report 20048812 ↗InjuryJun 21, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (FX103T) WAS IMPLANTED TOGETHER WITH A PROGAV 2.0 (#FX410T) DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALE CAUSED AN 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: 1 YEAR. HEIGHT: 76 CM. WEIGHT: 6 KG. GENDER: FEMALE. *SAME INCIDENT/PATIENT AS MEDWATCH#3004721439-2024-00160.
Patient problems: Hydrocephalus
MAUDE report 19587369 ↗InjuryAug 25, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 70 YEARS. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. GENDER: UNKNOWN. SAME EVENT AS #3004721439-2023-00245.
Patient problems: Hydrocephalus
MAUDE report 17623896 ↗InjuryAug 2, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON JULY 3, 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 MONTHS . WEIGHT: 6.5 KILOGRAMS (KG) . HEIGHT: 62 CENTIMETERS (CM). GENDER: UNKNOWN. SAME EVENT AS #3004721439-2023-00220.
Patient problems: Hydrocephalus
MAUDE report 17442429 ↗
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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