proSA® FV701TRecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04041906133023), received between Aug 6, 2020 and Jan 20, 2026 — classified as 78 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (60 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. 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. SAME EVENT/ PATIENT AS # 3004721439-2026-00013.

  Patient problems: Hydrocephalus

  MAUDE report 24114901 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED 10 YEARS AGO. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 23358451 ↗
• InjuryOct 20, 2025Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT THE PATIENT WAS IMPLANTED WITH A PROSA VALVE 10 YEARS AGO. REPORTEDLY THE SURGEON RECENTLY HAD TO DO A SHUNT REVISION AND IT APPEARED THE PROSA WASN'T WORKING SO THE SURGEON EXPLANTED THE VALVE AND WANTS TO SEND IT TO FOR TESTING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 23341380 ↗
• InjuryJul 11, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. 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 # 3004721439-2025-00188.

  Patient problems: Hydrocephalus

  MAUDE report 22478042 ↗
• InjuryFeb 24, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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.

  Patient problems: Hydrocephalus

  MAUDE report 21447712 ↗
• InjuryFeb 24, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. (IMPLANTATION DATE, ACCORDING TO QUESTIONNAIRE, IS BEFORE PRODUCTION DATE) ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS # 3004721439-2025-00038.

  Patient problems: Hydrocephalus

  MAUDE report 21446677 ↗
• InjurySep 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 15 YEARS WEIGHT: 33 KGS HEIGHT: 141 CM GENDER: MALE SAME EVENT AS # 3004721439-2024-00299.

  Patient problems: Hydrocephalus

  MAUDE report 20320877 ↗
• InjurySep 18, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 53 KGS HEIGHT: 170 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20245585 ↗
• InjuryJul 17, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2013. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 11 YEARS, 3 MONTHS. WEIGHT: 36 KGS. HEIGHT: 152 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00193.

  Patient problems: Hydrocephalus

  MAUDE report 19760304 ↗
• InjuryFeb 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 12 YEARS. WEIGHT: 48 KGS. HEIGHT: 148 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00042.

  Patient problems: Hydrocephalus

  MAUDE report 18763412 ↗
• InjuryFeb 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE HAD ADJUSTMENT DIFFICULTIES. 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: 81 YEARS, HEIGHT: 180 CM, WEIGHT: 80 KG.

  Patient problems: Hydrocephalus

  MAUDE report 18762179 ↗
• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROSA (#FV100T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2019. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED A MALFUNCTION AND THE PATIENT DESCRIBED CLICKING THAT HE COULD TRIGGER BY MOVING HIS NECK. 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: 36 YEARS; WEIGHT: 100 KGS; HEIGHT: 185 CM; GENDER: UNKNOWN; SAME EVENT AS # 3004721439-2024-00011.

  Patient problems: Hydrocephalus

  MAUDE report 18630721 ↗
• InjuryJan 11, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN ADJUSTMENT DIFFICULTIES. 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: 48 YEARS. HEIGHT: 186 CM. WEIGHT: 128 KG. GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 18498159 ↗
• InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED COMBINED WITH A PROGAV 2.0 (#FX410T) AND A SHUNTASSISTANT (FV252T) DURING A PROCEDURE PERFORMED ON (B)(6) 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 #3004721439-2023-00357.

  Patient problems: Hydrocephalus

  MAUDE report 18247000 ↗
• InjuryNov 20, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE AND ADJUSTMENT PROBLEMS. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 13 YEARS, WEIGHT: 68 KGS, HEIGHT: 140 CM, GENDER: FEMALE, SAME EVENT AS # 3004721439-2023-00350.

  Patient problems: Hydrocephalus

  MAUDE report 18173005 ↗
• InjuryAug 25, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA(#FV701T) 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 UNKNOWN. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 13 YEARS WEIGHT: 20 KILOGRAMS (KG). HEIGHT: 130 CENTIMETERS (CM). GENDER: MALE. SAME EVENT AS #3004721439-2023-00251.

  Patient problems: Hydrocephalus

  MAUDE report 17627577 ↗
• InjuryAug 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (FV701T) COMBINED WITH A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE VALVES CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 18 YEARS; HEIGHT: 160 CENTIMETERS (CM); WEIGHT: 56 KILOGRAMS (KG); GENDER: MALE. SAME PATIENT/ EVENT AS MEDWATCH#3004721439-2023-00231 (PROGAV).

  Patient problems: Hydrocephalus

  MAUDE report 17443247 ↗
• InjuryJun 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN 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: 13 YEARS, HEIGHT: 133 CENTIMETERS (CM), WEIGHT: 29.4 KILOGRAMS (KG), GENDER: MALE. SAME PATIENT / EVENT AS MEDWATCH#3004721439-2023-00167.

  Patient problems: Hydrocephalus

  MAUDE report 17131572 ↗
• InjuryMay 26, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDERDRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 12 YEARS; WEIGHT: 43 KILOGRAMS (KG); HEIGHT: 160 CENTIMETERS (CM); GENDER: MALE. SAME EVENT AS #3004721439-2023-00145.

  Patient problems: Hydrocephalus

  MAUDE report 17014613 ↗
• InjuryNov 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA (PART # FV701T) 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 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: 49 YEARS. HEIGHT: 180 CENTIMETERS (CM). WEIGHT: 80 KILOGRAMS (KG). GENDER: FEMALE. SAME EVENT AS #3004721439-2022-00338.

  Patient problems: Hydrocephalus

  MAUDE report 15781509 ↗
• InjuryOct 26, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (PART # FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. 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: 104 CENTIMETERS (CM), WEIGHT: 14.5 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15677396 ↗
• InjuryOct 26, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA VALVE (PART # FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED 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: 8.1 YEARS, HEIGHT: 125 CENTIMETERS (CM), WEIGHT: 17 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15677013 ↗
• MalfunctionOct 12, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA (PART # FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE SETTING ADJUSTED WITHOUT INTERVENTION. REPORTEDLY, THE LAST VALVE ADJUSTMENT WAS PERFORMED APPROXIMATELY TWO (2) YEARS AGO, WHEN IT WAS SET TO ELEVEN (11). ON (B)(6) 2022, THE PATIENT CAME INTO THE CLINIC CLAIMING TO HAVE BEEN FEELING WORSE. AT THAT TIME, THE VALVE WAS DISCOVERED TO HAVE CHANGED FROM ELEVEN (11) TO FOUR (4) WITHOUT PROGRAMMING. THE SHUNT WAS ADJUSTED BACK TO ELEVEN (11). ADDITIONALLY, THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE PRIOR TO THEIR VISIT TO THE CLINIC. NO REVISION SURGERY IS SCHEDULED AT THIS TIME. THEREFORE, THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT DATA WAS MADE AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 15591616 ↗
• InjuryOct 12, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (PART # FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. 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# 3004721439-2022-00308.

  Patient problems: Hydrocephalus

  MAUDE report 15591482 ↗
• InjuryOct 5, 2022Infusion or Flow Problem; Infusion or Flow Problem

  INVESTIGATION COMPLETE.

  Patient problems: Headache

  MAUDE report 15546440 ↗