AESCULAP FV128TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · DUALSWITCH-VALVE 10/40 L P DERIVATION · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906103804), received between Dec 2, 2021 and May 15, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).
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
- Infusion or Flow Problem2
- Mechanical Problem1
Patient problems
- Hydrocephalus3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DSV VALVE (#FV128T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22030197 ↗InjuryMar 6, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DSV (#FV128T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 15 YEARS. HEIGHT: 180 CM. WEIGHT: 70 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 18847020 ↗InjuryDec 2, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A VALVE WAS NOT DRAINING POSTOPERATIVELY. THE DEVICE WAS ORIGINALLY IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED DUE TO KINKING OF CATHETER AND NON-DRAINAGE ON (B)(6) 2017; BOTH THE CATHETER AND THE DUAL SWITCH VALVE WERE REPLACED. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12919402 ↗
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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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