AESCULAP FV044TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · SPRUNG RESERVOIR 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906131371), received between Feb 10, 2023 and Feb 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED TO AESCULAP INC. THAT A SPRUNG RESERVOIR W/DISTAL CATHETER (PRODUCT#: FV044T) WAS IMPLANTED DURING A PROCEDURE ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE DEVICE WAS EXPLANTED ON (B)(6) 2023 FROM THE PATIENT AS THE DOCTOR SUSPECTED IT HAD BECOME OCCLUDED. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE:( B)(4). ASSOCIATED MEDWATCH REPORTS: 400585755- 2916714-2023-00024-MDR, 400585899- 2916714-2023-00025-MDR.
Patient problems: Failure of Implant
MAUDE report 16350571 ↗
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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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