proGAV 2.0® FX349TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SPRUNG RESERVOIR · Class 2 · Implant
All models of proGAV 2.0 (49)
Data updated Oct 16, 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 04041906139988), received between Oct 29, 2022 and Jan 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Infusion or Flow Problem1
- Material Integrity 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.
InjuryJan 11, 2024Infusion or Flow Problem; Infusion or Flow Problem
CORRECTION: PATIENT AGE: 16 YEARS. THE SAMPLE WAS RETUREND FOR EVALUATION TO MANUFACTURER ON 03/18/2024.
Patient problems: Hydrocephalus
MAUDE report 18498308 ↗InjuryOct 29, 2022Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM WITH RESERVOIR (PART # FX349T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE METAL CONNECTOR OF THE RESERVOIR (CONNECTING TO THE BRAIN CATHETER) BROKE WHEN THE PATIENT FELL. THE DAMAGED PRODUCT IS STILL IN THE PATIENT'S BODY, BUT A REPLACEMENT IS PLANNED.
Patient problems: Hydrocephalus
MAUDE report 15695066 ↗
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- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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