proSA® FV713TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906133955), received between Jan 13, 2021 and Apr 14, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (#FV713T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 13 YEARS. WEIGHT: 30 KILOGRAMS (KG). HEIGHT: 125 CENTIMETERS (CM). GENDER: FEMALE. SAME EVENT AS #3004721439-2023-00086.

  Patient problems: Hydrocephalus

  MAUDE report 16744505 ↗
• InjuryFeb 8, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (PART # FV713T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 10.6 YEARS. HEIGHT: 147 CENTIMETERS (CM). WEIGHT: 38 KILOGRAMS (KG). GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2023-00019.

  Patient problems: Hydrocephalus

  MAUDE report 16329585 ↗
• InjuryMar 29, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROSA (PART # FV713T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. 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: (B)(6). HEIGHT: 178 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 13943976 ↗
• MalfunctionFeb 17, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROSA (PART # FV713T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. A NEW VALVE WAS ABLE TO BE USED, AND THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549843 ↗
• InjuryOct 15, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROSA WAS DIFFICULT TO REPROGRAM POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED IN (B)(6) 2016. TLHE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12639089 ↗
• InjuryJan 13, 2021Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  THE INVESTIGATION HAS BEEN COMPLETED AND WILL BE SUBMITTED WITH THE FOLLOW UP REPORT. THE RELEASE FOR INVESTIGATION RECEIVED ON (B)(6) 2021. THE SURGEON SUSPECTED THAT THE PROSA HAD AN INCREASED FLOW. NO FURTHER PATEINT INFORMATIONS ARE AVAILABLE. "ASSOCIATED MEDWATCHES: 3004721439-2020-00278 , MDR # - SAME PATIENT".

  Patient problems: Hydrocephalus

  MAUDE report 11164699 ↗