proGAV 2.0® FX353TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SA25 A.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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906140021), received between Jun 8, 2023 and Jun 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging 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 16, 2026.
Most reported problems
Device problems
- Packaging 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.
MalfunctionJun 8, 2023Packaging Problem; Packaging Problem
A STERILE PACKAGING ISSUE WAS REPORTED. ACCORDING TO THE COMPLAINANT, THE INTERNAL STERILE PACKAGING WAS NOT SEALED. THE SCOUT NURSE OPENED EXTERNAL STERILE PACKAGING TO HAND OVER ONTO STERILE FIELD FOR IMPLANTATION. THE VALVE WAS PLACED BETWEEN TWO LAYERS OF STERILISATION STERIPEEL PACKAGING WHICH WAS NOT SEALED AND THEREFORE THE VALVE FELL TO FLOOR WHEN THE SURGEON TRIED TO TAKE IT FROM THE SCOUT NURSE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE INCIDENT. THE SAMPLE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 17094113 ↗
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- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- 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
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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