SHUNTASSISTANT 2.0 FX102TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04041906501587), received between Apr 12, 2022 and Aug 4, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJul 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (#FX102T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN N(B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER- DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 MONTHS HEIGHT: 70 CENTIMETERS (CM) WEIGHT: 8 KILOGRAMS (KG) SAME INCIDENT AS MEDWATCH#3004721439-2023-00188.

  Patient problems: Hydrocephalus

  MAUDE report 17330111 ↗
• InjurySep 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX102T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 2 YEARS 7 MONTH. HEIGHT: 94 CENTIMETERS (CM). WEIGHT: 11 KILOGRAMS (KG). GENDER: MALE SAME EVENT AS MEDWATCH# 3004721439-2022-00280.

  Patient problems: Hydrocephalus

  MAUDE report 15465026 ↗
• InjuryJul 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FX102T) 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. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 5 YEARS. HEIGHT: 119 CENTIMETERS (CM). WEIGHT: 16 KILOGRAMS (KG). GENDER: FEMALE. SAME PATIENT / EVENT AS MEDWATCH # 3004721439-2022-00218.

  Patient problems: Hydrocephalus

  MAUDE report 15117373 ↗
• InjuryMay 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 20 (PART # FX102T) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 TO EXPLANT A SHUNT ASSISTANT ALONG WITH ANOTHER MANUFACTURER'S VALVE. REPORTEDLY, WHEN THE NEW SHUNT ASSISTANT (PART # FV251T) (REF. MDR ID 2916714-2022-00052) WAS HOOKED UP TO A MANOMETER, THE VALVE DID NOT APPEAR TO WORK WITH THE MANOMETER. REPORTEDLY, IT DID NOT SHUT OFF WHEN IN THE UPRIGHT POSITION. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE EXPLANTED VALVE WAS ACCIDENTALLY DISPOSED OF BY THE HOSPITAL COORDINATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. A FIVE (5) MINUTE DELAY WAS REPORTED AS A RESULT OF THE EVENT. IT IS THE SAME PATIENT AS MDR ID # 2916714-2022-00052.

  Patient problems: Hydrocephalus

  MAUDE report 14519567 ↗
• InjuryMay 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 20 (PART # FX102T) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 TO EXPLANT A SHUNT ASSISTANT ALONG WITH ANOTHER MANUFACTURER'S VALVE. REPORTEDLY, WHEN THE NEW SHUNT ASSISTANT (PART # FV251T) (REF. MDR ID 3004721439-2022-00138) WAS HOOKED UP TO A MANOMETER, THE VALVE DID NOT APPEAR TO WORK WITH THE MANOMETER. REPORTEDLY, IT DID NOT SHUT OFF WHEN IN THE UPRIGHT POSITION. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE EXPLANTED VALVE WAS ACCIDENTALLY DISPOSED OF BY THE HOSPITAL COORDINATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. A FIVE (5) MINUTE DELAY WAS REPORTED AS A RESULT OF THE EVENT. IT IS THE SAME PATIENT AS MDR ID # 3004721439-2022-00138.

  Patient problems: Hydrocephalus

  MAUDE report 14519562 ↗
• InjuryApr 12, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON JANUARY 18, 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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. AGE: (B)(6), HEIGHT: 71 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: MALE. SAME EVENT AS MEDWATCH MDR ID 3004721439-2022-00077.

  Patient problems: Hydrocephalus

  MAUDE report 14091500 ↗
• InjuryApr 12, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 (PART # FX102T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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. AGE: (B)(6), HEIGHT: 71 CENTIMETERS (CM), WEIGHT:(B)(6), GENDER: MALE. SAME EVENT AS MEDWATCH MDR ID 3004721439-2022-00078.

  Patient problems: Hydrocephalus

  MAUDE report 14091380 ↗