AESCULAP FV100TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · DUALSWITCH-VALVE 10/30 · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906101008), received between Dec 14, 2021 and Dec 5, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 Problem3
- Break1
- Mechanical Problem1
Patient problems
- Hydrocephalus5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DSV VALVE (#FV119T) WAS IMPLANTED ON (B)(6) 2025. 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 NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23726572 ↗InjuryJul 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DUALSWITCHVALVE (DSV) (#FV100T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22470957 ↗InjuryApr 27, 2022Break; Break
IT WAS REPORTED THAT A DUALSWITCH-VALVE 10/30 (PART # FV100T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2002. ACCORDING TO THE COMPLAINANT, THE ABDOMINAL CATHETER HAS RUPTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6). HEIGHT: 162.5 CENTIMETERS (CM). WEIGHT: (B)(6) (KG). GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 14218247 ↗InjuryApr 5, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DUALSWITCH-VALVE 10/30 (DSV) (PART # FV100T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), HEIGHT: (B)(6), WEIGHT: (B)(6), GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 14017476 ↗InjuryDec 14, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A DUALSWITCH-VALVE OPERATED IN OVER-DRAINAGE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 168 CM.
Patient problems: Hydrocephalus
MAUDE report 13005495 ↗
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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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