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proGAV® FV433TRecalls & reported problems

Christoph Miethke GmbH & Co. KG · PROGAV SYS W/SA 15 A.CONTROL RESERVOIR · Class 2 · Implant

All models of proGAV (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906132453), received between Dec 10, 2020 and Nov 30, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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

Device problems

  • Mechanical Problem5
  • Infusion or Flow Problem2

Patient problems

  • Hydrocephalus6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem

    ACCORDING TO THE COMPLAINANT A PROGAV HAD A FAILURE DURING USE. THE PATIENT WAS ORIGINALLY SCHEDULED FOR IMPLANTATION ON (B)(6) 2017; THERE WAS NO CHANGE IN VALUE AND DEVICE WOULD NOT CALIBRATE EVEN AFTER MULTIPLE ATTEMPTS. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

    Patient problems: Hydrocephalus

    MAUDE report 12892818 ↗
  • MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem

    ACCORDING TO THE COMPLAINANT A PROGAV HAD A FAILURE DURING USE. THE PATIENT WAS ORIGINALLY SCHEDULED FOR IMPLANTATION ON (B)(6) 2017; THE DEVICE WOULD NOT CALIBRATE. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

    Patient problems: Hydrocephalus

    MAUDE report 12892810 ↗
  • InjuryNov 1, 2021Mechanical Problem; Mechanical Problem

    ACCORDING TO THE COMPLAINANT A PROGAV HAD A "DYSFUNCTION" POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016.. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

    Patient problems: Hydrocephalus

    MAUDE report 12728851 ↗
  • InjuryOct 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV433T -PROGAV SYS W/SA 15 A.CONTROL RESERVOIR ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

    Patient problems: Hydrocephalus

    MAUDE report 12658545 ↗
  • InjurySep 16, 2021Mechanical Problem; Mechanical Problem

    ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF POSTOPERATIVE OCCLUSION. THE PATIENT WAS ORIGINALLY IMPLANTED AT AN UNSPECIFIED TIME. THE EVENT DATE WAS NOTED AS (B)(6) 2016. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

    Patient problems: Hydrocephalus

    MAUDE report 12480915 ↗
  • InjuryDec 10, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNT SYSTEM. THE SURGEON REPLACED THE SHUNT SYSTEM DUE TO SUSPECTED OVERDRAINAGE AND ADJUSTMENT PROBLEMS. PATIENT INFORMATIONS: AGE: (B)(6) YEARS. HEIGHT: 150 CM. WEIGHT: (B)(6) KG. IMPLANTATION: (B)(6) 2009. REMOVAL: (B)(6) 2020.

    Patient problems: Hydrocephalus

    MAUDE report 10983135 ↗

Other Shunt, central nervous system and components devices

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Sources and updates

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