ShuntAssistant® FV251TRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04041906113209), received between Oct 9, 2020 and Jun 18, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (22 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A SHUNT ASSISTANT (#F251T) WAS IMPLANTED AND LATER COMBINED WIT ANOTHER PROGAV 2.0 SHUT SYSTEM ON AN UNSPECIFIED DATE. 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. THIS PARTICULAR VALVE WAS SENT ADDITIONALLY TO RM (B)(4) CC400709572. PRIOR TO RECEIVING THE ORIGINALLY REPORTED SHUNT SYSTEM, WE HAD NO KNOWLEDGE OF THIS SHUNT ASSISTANT. RM (B)(4) CC400709572 IS REPORTED WITH MEDWATCH NO.: 3004721439-2025-00149.

  Patient problems: Hydrocephalus

  MAUDE report 22284332 ↗
• InjuryMar 31, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A SHUNT ASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT 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 21730372 ↗
• InjuryMay 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT(#FV251T) WAS IMPLANTED DURING A PROCEDURE. 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: 5 MONTHS. HEIGHT: 56 CM. WEIGHT: 4.95 KG. GENDER: MALE. SAME EVENT AS MEDWATCH#3004721439-2024-00106 + MEDWATCH#3004721439-2024-00108.

  Patient problems: Hydrocephalus

  MAUDE report 19226188 ↗
• InjuryMar 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 16 YEARS WEIGHT: 38 KGS HEIGHT: 153 CM GENDER: MALE SAME EVENT AS # 3004721439-2024-00055.

  Patient problems: Hydrocephalus

  MAUDE report 18848401 ↗
• InjuryOct 4, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 10 YEARS, HEIGHT: 132 CENTIMETERS, WEIGHT: 25 KILORGRAMS, GENDER: MALE. SAME PATIENT/EVENT AS MEDWATCH NO.:3004721439-2023-00289.

  Patient problems: Hydrocephalus

  MAUDE report 17872611 ↗
• InjuryMay 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A BLOCKAGE THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 56 YEARS. SAME EVENT AS # 3004721439-2023-00122

  Patient problems: Hydrocephalus

  MAUDE report 16913330 ↗
• InjuryApr 3, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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. AGE: 9 YEARS. HEIGHT: 90 CENTIMETERS (CM). WEIGHT: 40 KILOGRAMS (KG). GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2023-00067.

  Patient problems: Hydrocephalus

  MAUDE report 16668655 ↗
• InjuryFeb 28, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE. 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. AGE: 18 YEARS. HEIGHT: 165 CENTIMETERS (CM). WEIGHT: 65 KILOGRAMS (KG). GENDER: MALE. SAME EVENT MEDWATCH MDR ID # 3004721439-2023-00031.

  Patient problems: Hydrocephalus

  MAUDE report 16452967 ↗
• InjuryJan 20, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND NON-ADJUSTABILITY. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2022. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS (B)(4)/ 3004721439-2022-00428.

  Patient problems: Hydrocephalus

  MAUDE report 16219209 ↗
• InjuryJan 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND NON-ADJUSTABILITY. 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: 6 YEARS, HEIGHT: 120 CENTIMETERS (CM), WEIGHT: 15 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS: #3004721439-2022-00418.

  Patient problems: Hydrocephalus

  MAUDE report 16199860 ↗
• InjuryDec 15, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FX251T) 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 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: 6 YEARS. HEIGHT: 104 CENTIMETERS (CM). WEIGHT: 13 KILOGRAMS (KG). GENDER: UNKNOWN. SAME EVENT AS MEDWATCH# 3004721439-2022-00372.

  Patient problems: Hydrocephalus

  MAUDE report 15988415 ↗
• InjuryDec 7, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE 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: 6 YEARS, HEIGHT: 118 CENTIMETERS (CM), WEIGHT: 27 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MDR ID # 3004721439-2022-00365.

  Patient problems: Hydrocephalus

  MAUDE report 15936661 ↗
• InjuryOct 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED 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: 13 YEARS. HEIGHT: 153 CENTIMETERS (CM). WEIGHT: 53 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15677117 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 10 YEARS. HEIGHT: 130 CENTIMETERS (CM). WEIGHT: 26 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH #: 3004721439-2022-00262.

  Patient problems: Hydrocephalus

  MAUDE report 15320754 ↗
• InjuryAug 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN 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. AGE: 5 YEARS, HEIGHT: 90 CENTIMETERS (CM), WEIGHT: 12 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2022-00256.

  Patient problems: Hydrocephalus

  MAUDE report 15306667 ↗
• InjuryJun 1, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 20 WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE 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) YEARS. HEIGHT: 104 CENTIMETERS (CM). WEIGHT: (B)(6) KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 14566870 ↗
• InjuryMay 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT 20 (PART # FV251T) WAS TO BE IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 TO EXPLANT A SHUNT ASSISTANT (PART # FX102T) (REF. MDR ID 3004721439-2022-00137) 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. THE OTHER COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 14519709 ↗
• InjuryMay 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 20 PART # FV251T WAS TO BE IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 TO EXPLANT A SHUNT ASSISTANT PART # FX102T REF. MDR ID 2916714-2022-00051) ALONG WITH ANOTHER MANUFACTURER'S VALVE. REPORTEDLY, WHEN THE NEW SHUNT ASSISTANT PART # FV251T 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. THE OTHER COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. A FIVE MINUTE DELAY WAS REPORTED AS A RESULT OF THE EVENT. IT IS THE SAME PATIENT AS MDR ID # 2916714-2022-00051.

  Patient problems: Hydrocephalus

  MAUDE report 14519561 ↗
• InjuryApr 19, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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: (B)(6). HEIGHT: 150 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE. SAME EVENT AS MEDWATCH MDR ID 3004721439-2022-00110.

  Patient problems: Hydrocephalus

  MAUDE report 14141224 ↗
• InjuryApr 14, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV251T) 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 ON AN UNKNOWN DATE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH MDR ID 3004721439-2022-00103.

  Patient problems: Hydrocephalus

  MAUDE report 14114017 ↗
• InjuryDec 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT 20 (PART # FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) YEARS, WEIGHT: (B)(6) KILOGRAMS (KG), HEIGHT: 78 CENTIMETERS (CM), GENDER: UNKNOWN. SAME EVENT AS MEDWATCH # 3004721439-2021-00312.

  Patient problems: Hydrocephalus

  MAUDE report 12911353 ↗
• InjurySep 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE COMPLAINANT A SHUNT ASSISTANT WAS SUSPECTED TO HAVE A BLOCKAGE. THE PATIENT UNDERWENT AN IMPLANT PROCEDURE ON (B)(6) /2021. THE PROCEDURE WAS A LATERAL VENTRICULAR PERITONEAL SHUNT PLACEMENT. DUE TO THE BLOCKAGE, THE SHUNT NEEDED TO BE ADJUSTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), HEIGHT: UNKNOWN, WEIGHT: UNKNOWN, GENDER: MALE. PREOPERATIVE DIAGNOSIS: SEVERE CRANIOCEREBRAL INJURY, DUE TO CAR ACCIDENT. (IS THE SAME PATIENT AS #(B)(6)).

  Patient problems: Hydrocephalus

  MAUDE report 12521243 ↗
• InjurySep 1, 2021Infusion or Flow Problem; Pressure Problem; Infusion or Flow Problem; Pressure Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV251T- SHUNTASSISTANT 20. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CUSTOMER ASKS FOR VERIFICATION OF THE CORRECT OPENING PRESSURE. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 12410428 ↗
• InjuryAug 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE AND WAS DIFFICULT TO ADJUST. 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: 161 CENTIMETERS (CM), WEIGHT: (B)(6) (KG), GENDER: MALE. SAME EVENT #MEDWATCH: 3004721439-2021-00223.

  Patient problems: Hydrocephalus

  MAUDE report 12304763 ↗
• InjuryApr 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNT ASSISTANT (#FV251T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE. 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. PATIENT INFORMATION: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11657047 ↗