AESCULAP FV077PRecalls & reported problems
Christoph Miethke GmbH & Co. KG · Ventricular Catheter marked, with mandrin, 9 3/4" (250 mm), inner diam. 1,20 mm, outer diam. 2,50 mm, silicone, sterile, disposable · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906120405), received between Feb 9, 2022 and Sep 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem1
- Microbial Contamination of Device1
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Microbial Contamination of Device; Microbial Contamination of Device
CUSTOMER REPORTED A CASE OF INFECTION WITH A VETRICULAR CATHTER (#FV077P) NO PATIENT DATA AVAILABLE. NO PATIENT HARM REPORTED. SAME EVENT AS #3004721439-2025-00259, #3004721439-2025-00260.
Patient problems: Hydrocephalus
MAUDE report 23017658 ↗InjuryFeb 9, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A VENTRICULAR CATHETER (PART # FV077P) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN MALFUNCTION. 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. ASSOCIATED MEDWATCH REPORT #3004721439-2022-00013 AND 3004721439-2022-00015
Patient problems: Hydrocephalus
MAUDE report 13502095 ↗
Other CATHETER, VENTRICULAR devices
- CODMAN® HAKIM® BACTISEAL® NS5524Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR1 recall1 report
- CODMAN® BACTISEAL® NS0339Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR6 reports
- CODMAN® BACTISEAL® NS0340Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR5 reports
- CODMAN® BACTISEAL® NS0338Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR3 reports
- CODMAN® CERTAS® Plus 828827PLIntegra LifeSciences Switzerland Sàrl · CATHETER, VENTRICULAR1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.