proSA® FX991TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04041906138493), received between Nov 19, 2020 and Dec 9, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (#FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. 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 20877998 ↗
• InjuryFeb 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (#FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, , THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND 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: 55 YEARS. HEIGHT: 165 CM. WEIGHT: 95 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18762186 ↗
• InjuryJan 4, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNT SYSTEM (#FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND 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: 56 YEARS, HEIGHT: 180 CENTIMETERS (CM), WEIGHT: 100 KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16099058 ↗
• InjuryDec 9, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM WITH PROGAV 2.0 (PART # FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 32 YEARS. HEIGHT: 165 CENTIMETERS (CM). WEIGHT: 110 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15954736 ↗
• InjuryMar 2, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (PART # FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. 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)(4) 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: 140 CENTIMETERS (CM). WEIGHT: (B)(4). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 13656493 ↗
• InjuryDec 7, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROSA WAS NOT ADJUSTABLE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 170 CM

  Patient problems: Hydrocephalus

  MAUDE report 12954428 ↗
• MalfunctionOct 6, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. (PART # FX991T) WAS TESTED PRIOR TO BEING USED. ACCORDING TO THE COMPLAINANT, RESISTANCE WAS EXPERIENCED WHEN THE VALVE WAS TESTED IN THE VERTICAL POSITION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: Hydrocephalus

  MAUDE report 12586796 ↗
• InjuryApr 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA SYSTEM WITH PROGAV 2.0 (PART # FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) , 2018. ACCORDING TO THE COMPLAINANT, THE VALVES WERE BELIEVED TO BE OPERATING IN UNDER-DRAINAGE. THE VENTRICLES OF THE PATIENT WERE DILATED. 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) YEARS. WEIGHT: 15 KILOGRAMS (KG). HEIGHT: 101 CENTIMETERS (CM). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11734804 ↗
• InjuryMar 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNTSYSTEM. THE SURGEON SUSPECTED AN UNDERDRAINAGE PATIENT INFORMATION: AGE: (B)(6)YEAR, HEIGHT: 167 CM, WEIGHT: (B)(6) KG, GENDER: FEMALE. IMPLANTATION: (B)(6) 2019. EXPLANATION: (B)(6) 2021.

  Patient problems: Hydrocephalus

  MAUDE report 11515389 ↗
• InjuryFeb 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE INVESTIGATION IS COMPLETED ON 02/24/2021.

  Patient problems: Hydrocephalus

  MAUDE report 11368206 ↗
• InjuryNov 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNTSYSTEM WITH PROGAV 2.0. THE SURGEON SUSPECTED THAT THE SHUNTSYSTEM OPERATED IN UNDER-DRAINAGE. PATIENT INFORMATION: AGE: (B)(6), HEIGHT: UNKNOWN, WEIGHT: UNKNOWN, GENDER: MALE. IMPLANTATION: (B)(6) 2019, REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10868323 ↗