AESCULAP FV048TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · CONTROLRESERVOIR W/DISTAL CATHETER · Class 2 · Implant
Data updated Oct 13, 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 04041906131470), received between Dec 2, 2021 and Dec 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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
- 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.
MalfunctionDec 2, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A CONTROL RESERVOIR WOULD NOT FLUSH. AFTER ATTACHING THE CONTROL RESERVOIR TO THE PROGAV2 AND 25 SHUNT ASSISTANT COMBO, THE SURGEON ATTEMPTED TO FLUSH THE DEVICE AND WAS UNSUCCESSFUL. AFTER SEPARATING IT, HE TRIED AGAIN AND IT WOULD NOT FLUSH; IT EVENTUALLY FLUSHED AFTER REPEATED ATTEMPTS BUT IT TOOK A WHILE FOR THE BALL BEARING TO BE MOVED. THUS IT WAS NOT IMPLANTED AND ANOTHER RESERVOIR WAS USED INSTEAD. THE EVENT DATE WAS NOTED AS (B)(6) 2017. THERE WAS NO PATIENT HARM. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12919408 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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