SHUNTASSISTANT 2.0 FX103TRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04041906501594), received between Mar 4, 2021 and Jun 8, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (14 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(4) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. REFERENCE ASSOCIATED MEDWATCH REPORT MDR ID # 3004721439-2023-00010.

  Patient problems: Hydrocephalus

  MAUDE report 16312462 ↗
• InjuryDec 15, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART#: FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE BLOCKED. 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 MONTH, HEIGHT: 62 CENTIMETERS (CM), WEIGHT: 7 KILOGRAMS (KG), GENDER: UNKNOWN. SAME EVENT AS MEDWATCH#: 3004721439-2022-00382.

  Patient problems: Hydrocephalus

  MAUDE report 15989850 ↗
• InjuryDec 1, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE 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. SAME EVENT AS MEDWATCH#3004721439-2022-00362.

  Patient problems: Hydrocephalus

  MAUDE report 15895377 ↗
• InjuryOct 12, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND UNDERDRAINAGE. 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. SAME EVENT AS MEDWATCH # 3004721439-2022-00309.

  Patient problems: Hydrocephalus

  MAUDE report 15591500 ↗
• InjuryApr 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE 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: (B)(6), HEIGHT: 105 CENTIMETERS (CM), WEIGHT: (B)(6) (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 14253285 ↗
• InjuryNov 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 VALVE WAS IMPLANTED DURING A PROCEDURE PERFORMED IN ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), HEIGHT: 62 CM, WEIGHT: (B)(6) KG, GENDER: FEMALE. IS THE SAME PATIENT AS # 3004721439-2021-00301 (ASSOCIATED MEDWATCH).

  Patient problems: Hydrocephalus

  MAUDE report 12804624 ↗
• InjuryMay 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. 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: (B)(6) HEIGHT: 60 CM WEIGHT: (B)(6) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11878552 ↗
• InjuryMay 21, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT2.0 (#FX103T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE VENTRICLE WERE DILATED. 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: (B)(6), HEIGHT: 61 CM, WEIGHT: (B)(6), GENDER: MALE, SAME EVENT: MEDWATCH 3004721439-2021-00138.

  Patient problems: Hydrocephalus

  MAUDE report 11864422 ↗
• InjuryMay 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A SHUNTASSISTANT 2.0 25 (PART # FX103T) AND A PROGAV 2.0 VALVE (PART # FX410T) (REF. MDR ID 3004721439-2021-00127) WERE 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 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. IMPLANTATION: (B)(6) 2021. EXPLANTATION: (B)(6) 2021. AGE: (B)(6) MONTHS. WEIGHT: (B)(6) KILOGRAMS (KG). GENDER: MALE. THE SAME EVENT: MEDWATCH # 3004721439-2021-00127.

  Patient problems: Hydrocephalus

  MAUDE report 11845469 ↗
• MalfunctionMar 4, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE SURGEON SUSPECT A DYSFUNCTION OF THE VALVE DURING THE PREOPERATIVE FLOW TEST PRIOR TO USE. FIXED PRESSURE SA 2.0 VALVE WAS PRETESTED PRIOR TO IMPLANTATION. THE VALVE WAS TESTED IN VERTICAL AND HORIZONTAL POSITIONS. HENCE THE VALVE WAS TESTED MULTIPLE TIMES WITH SIMILAR OUTCOMES. MOREOVER, FLUSHING THE VALVE DID NOT ENHANCE VALVE PERFORMANCE. THE OPENING PRESSURE REMAINED HIGH AT APPROXIMATELY 50CMH2O. A SECOND SA 2.0 VALVE WAS TESTED AND DISPLAYED SIMILAR PERFORMANCE IN THE SAME CASE. A THIRD SA2.0 WAS TESTED AND PERFORMED ACCORDING TO EXPECTATIONS. THE SURGERY COULD BE COMPLETED. THE CASE WAS PROLONGED BY APPROXIMATELY 30-40 MINUTES. "ASSOCIATED MEDWATCHES: 3004721439-2021-00044, MDR#- SAME PATIENT/EVENT".

  Patient problems: Hydrocephalus

  MAUDE report 11411936 ↗