proSA® FX993TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROSA WITH PROGAV 2.0 A.DISTAL CATHETER · Class 2 · Implant
All models of proSA (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906138448), received between Aug 27, 2021 and Oct 5, 2021 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
- Mechanical Problem1
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FX993T - PROSA WITH PROGAV 2.0 A.DISTAL CATHETER. ACCORDING TO THE COMPLAINANT A PROSA VALVE WAS BELIEVED TO BE OVERDRAINAGE. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNSPECIFIED DATE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12579610 ↗InjuryAug 27, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PROSA WITH PROGAV 2.0 HAD A MALFUNCTION POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE VALVE IN QUESTION (PROGAV 2.0) WAS SET AND PRESSURE VERIFIED TO ENSURE CORRECTNESS. THE PATIENT RETURNED TO THE HOSPITAL MULTIPLE TIMES DUE TO HEADACHE, NAUSEA ETC. THE DOCTORS RESET THE PRESSURE AND IN EVERY INSTANCE THE VALVE ADJUSTED ITSELF. FINALLY, THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. THE NEW VALVE WAS WITHOUT ISSUES. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12377945 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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