proSA® FV770TRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04041906135553), received between Dec 3, 2020 and Jul 8, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA® (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2015. ACCORDING TO THE COMPLAINANT, THE PROSA VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN(B)(6) 2024; HOWEVER, THE EXACT DATE WAS NOT PROVIDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 19696356 ↗
• InjuryJun 6, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA® (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2015. ACCORDING TO THE COMPLAINANT, THE PROSA VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024; HOWEVER, THE EXACT DATE WAS NOT PROVIDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 19478397 ↗
• InjuryMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN IMPLANTED PROSA SHUNT SYSTEM (# FV770T), ACCORDINGLY TO THE COMPLAINANT, 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: 21 YEARS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19335157 ↗
• InjurySep 6, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM MIT PROGAV (#FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 58 YEARS. WEIGHT: 80 KILOGRAMS. HEIGHT: 178 CENTIMETERS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17691819 ↗
• InjuryMar 8, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNT SYSTEM (PART # FV770T) 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 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: 83 YEARS. HEIGHT: 178 CENTIMETERS (CM). WEIGHT: 85 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16507773 ↗
• InjuryJan 13, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (PART#: FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. 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: 54 YEARS 10 MONTH. HEIGHT: 180 CENTIMETERS (CM). WEIGHT: 93 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16162303 ↗
• InjuryNov 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNT SYSTEM WITH PROGAV (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND NOT ADJUSTABLE. 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: 28 YEARS. HEIGHT: 180 CENTIMETERS (CM). WEIGHT: 90 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15849754 ↗
• InjuryJun 15, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (#FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. 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: 75 YEARS, HEIGHT: 186 CM, WEIGHT: 100 KG, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 14691446 ↗
• InjuryApr 13, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNT SYSTEM (PART # FV770T) 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 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: 183 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 14091662 ↗
• InjuryJan 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES. (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. 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). WEIGHT: (B)(6). HEIGHT: 73 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13177644 ↗
• InjuryNov 16, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND WAS NOT ADJUSTABLE. 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: 168 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12821095 ↗
• InjuryOct 12, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (PART # FV770T) 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 DIFFERENT 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: 186 CM. WEIGHT: (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12619553 ↗
• InjuryAug 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO HAVE BEEN 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: (B)(6) CENTIMETERS (CM). WEIGHT: (B)(6) KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12342029 ↗
• InjuryDec 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNTSYTSEM. THE SURGEON SUSPECTED THAT THE SHUNTSYTSEM OPERATES IN UNDERDRAINAGE. THE SHUNTSYTSEM WAS REMOVED AND A NEW WAS IMPLANTED. PATIENT INFORMATIONS: AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: 185 CM. GENDER: MALE. DATE OF IMPLANTATION: (B)(6) 2016. DATE OF REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 11066501 ↗
• InjuryDec 3, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNT SYSTEM (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2010. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE FACILITY WITH INCREASED FATIGUE AND DOUBLE VISION BEGINNING ON SUNDAY (B)(6) 2020. THE PATIENT UNDERWENT A COMPUTED CRANIAL TOMOGRAPHY (CCT) WHICH REVEALED CLEAR BUILD-UP. THE X-RAY REVEALED A CORRECT VALVE SETTING AND NO INDICATION OF DISCONNECTION OR DISLOCATION. THE PHYSICIAN PUNCTURED THE SHUNT SYSTEM AND REMOVED 12 MILLILITERS (ML) OF CLEAR LIQUID. HOWEVER, THE VALVE COULD NOT BE INTRODUCED, SO A REVISION SURGERY WAS SCHEDULED FOR THE FOLLOWING DAY. THE REPLACEMENT SURGERY WAS PERFORMED ON (B)(6) 2020. THE PROSA SHUNT SYSTEM WAS REMOVED AND REPLACED WITH A PROGAV 2.0 WITH PROSA SYSTEM (PART # FX987T). HOWEVER, ON (B)(6) 2020, THE SURGEON DOCUMENTED THAT A SECOND REVISION WAS REQUIRED DUE TO SPONTANEOUS ADJUSTMENT WITH RENEWED ACCUMULATION OF THE PROGAV 2.0 (REF. MDR ID 3004721439-2020-00248). THE PROGAV 2.0 WITH PROSA SYSTEM WAS REPLACED WITH A PROSA SHUNT SYSTEM TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED FOLLOWIN

  Patient problems: Headache; Hydrocephalus; Visual Impairment

  MAUDE report 10942219 ↗