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proSA® FV702TRecalls & reported problems

Christoph Miethke GmbH & Co. KG · PROSA VALVE W/MININAV 0 · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906133030), received between Jun 29, 2021 and Jun 29, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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

Device problems

  • Infusion or Flow Problem1
  • Mechanical Problem1

Patient problems

  • Hydrocephalus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 29, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

    ADDITIONAL INFORMATION ARE AVAILABLE. ACCORDING TO THE COMPLAINANT, THE VALVE (PART # FV701T) WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AGE: 42 YEARS. HEIGHT: 163 CM. WEIGHT: 80 KG. SAME EVENT: MEDWATCH: 3004721439-2021-00186.

    Patient problems: Hydrocephalus

    MAUDE report 12088402 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.