ShuntAssistant® FV252TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04041906113308), received between Dec 29, 2020 and Nov 18, 2024 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT (# FV252T) WAS TESTED PREOPERATIVELY AND SHOWED UNEXPECTED BEHAVIOR. NO PATIENT INVOLVEMENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.

  Patient problems: Hydrocephalus

  MAUDE report 20705008 ↗
• MalfunctionNov 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS TESTED PREOPERATIVELY AND SHOWED UNEXPECTED BEHAVIOR. NO PATIENT INVOLVEMENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.

  Patient problems: Hydrocephalus

  MAUDE report 20704986 ↗
• InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS IMPLANTED COMBINED WITH A PROGAV 2.0 (#FX410T) AND A PROSA (#FV701T) DURING A PROCEDURE PERFORMED ON 11/24/2020. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 34 YEARS. HEIGHT: 160 CM. WEIGHT: 65 KG. GENDER: FEMALE. SAME EVENT AS MEDWATCH#3004721439-2023-00355 AND #3004721439-2023-00356.

  Patient problems: Hydrocephalus

  MAUDE report 18246931 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 8 YEARS; HEIGHT: 125 CENTIMETERS (CM); WEIGHT: 30 KILOGRAMS (KG); GENDER: MALE. SAME EVENT AS MEDWATCH-NO. 3004721439-2022-00268.

  Patient problems: Hydrocephalus

  MAUDE report 15324980 ↗
• InjuryJun 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 11 YEARS. HEIGHT: 140 CENTIMETERS (CM). WEIGHT: 36,9 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH-NO. 3004721439-2022-00146.

  Patient problems: Hydrocephalus

  MAUDE report 14631364 ↗
• InjuryMar 23, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNTASSISTANT 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: 175 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE. SAME EVENT AS MEDWATCH#3004721439-2022-00056

  Patient problems: Hydrocephalus

  MAUDE report 13869844 ↗
• InjuryNov 16, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  ADDITIONAL INFORMATION: A SURGICAL DELAY OF APPROXIMATELY THIRTY (30) MINUTES WAS REPORTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4); (B)(4).

  Patient problems: Intraoperative Pain; Needle Stick/Puncture

  MAUDE report 12824077 ↗
• InjuryNov 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A SHUNTASSISTANT 25 (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 50CM.

  Patient problems: Hydrocephalus

  MAUDE report 12799243 ↗
• InjuryNov 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A SHUNTASSISTANT 25 (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT ASSISTANT WAS BELIEVED TO BE UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12797759 ↗
• InjuryNov 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A SHUNTASSISTANT 25 (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT ASSISTANT WAS BELIEVED TO BE UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT : 52CM.

  Patient problems: Hydrocephalus

  MAUDE report 12790799 ↗
• InjuryNov 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON DET130 DEG UP 4MM 200MMREG (PART # FK915R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE KERRISON TIP BENT. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2021 WHICH REVEALED THAT THE PATIENT WAS INJURED DURING THE PROCEDURE. REPORTEDLY, A "DURAL TEAR" OCCURRED THAT THE SURGEON HAD TO PATCH. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Skin Tears

  MAUDE report 12782830 ↗
• InjurySep 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV252T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. 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: 109 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: UNKNOWN. SAME EVENT AS MEDWATCH # 3004721439-2021-00258.

  Patient problems: Hydrocephalus

  MAUDE report 12515599 ↗
• InjuryDec 29, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  THE INVESTIGATION OF THE DEVICE WAS COMPLETED AND WOULD BE SUBMITTED WITH THIS REPORT.

  Patient problems: Hydrocephalus

  MAUDE report 11089800 ↗