ShuntAssistant® FV250TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906113100), received between Feb 16, 2021 and Apr 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN SHUNTASSISTANT 15 (#FV250T) WAS IMPLANTED TO REDUCE THE SIZE OF THE VENTRICLE. ACCORDING TO THE HOSPITAL, IT SEEMED LIKE THE SHUNTASSISTANT WAS WORKING TOO WELL. BEFORE THE OPERATION, IT WAS CONFIRMED THAT THE SHUNT WAS NOT BLOCKED. THE EXAMINATION IS BEING CONDUCTED AS A PRECAUTION.

  Patient problems: Hydrocephalus

  MAUDE report 25001893 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN SHUNTASSISTANT 15 (#FV250T) WAS IMPLANTED TO REDUCE THE SIZE OF THE VENTRICLE. ACCORDING TO THE HOSPITAL, IT SEEMED LIKE THE SHUNTASSISTANT WAS WORKING TOO WELL. THEREFORE, AN ADDITIONAL SURGERY WAS PERFORMED TO SWITCH THE SHUNTASSISTANT WITH A PRESSURE SETTING OF 10.

  Patient problems: Hydrocephalus

  MAUDE report 25001840 ↗
• InjuryMar 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT 15 (PART # FV250T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE AND WAS DIFFICULT TO ADJUST. 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: 130 CENTIMETERS (CM). WEIGHT: (B)(6) (KG). GENDER: FEMALE. SAME EVENT AS MEDWATCH # 3004721439-2022-00062.

  Patient problems: Hydrocephalus

  MAUDE report 13896062 ↗
• InjuryDec 6, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 15 (PART # FV250T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. 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: UNKNOWN, WEIGHT: UNKNOWN, GENDER: MALE. SAME EVENT AS MEDWATCH # 3004721439-2021-00330.

  Patient problems: Hydrocephalus

  MAUDE report 12934883 ↗
• InjuryNov 1, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 15 (# FV250T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 12730317 ↗
• InjuryAug 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV250T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VLAVE WAS BELIEVED TO HAVE A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO FURTHER PATIENT DATA ARE AVAILABLE. THE SAME EVENT: MEDWATCH#3004721439-2021-00221.

  Patient problems: Hydrocephalus

  MAUDE report 12331156 ↗
• InjuryMay 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION: HEIGHT: 177 CM. WEIGHT: 62 KG. THE SAME EVENT: MEDWATCH#3004721439-2021-00135.

  Patient problems: Hydrocephalus

  MAUDE report 11848748 ↗
• InjuryFeb 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  "ASSOCIATED MEDWATCHES: 3004721439-2021-00019, 3004721439-2021-00021, 3004721439-2021-00022 MDR # - SAME PATIENT".

  Patient problems: Hydrocephalus

  MAUDE report 11334203 ↗