AESCULAP FV079TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PRECHAMBER SET VENTR.CATHETER 250MM · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 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 04041906120603), received between Oct 19, 2021 and Oct 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Perforation1
- Material Puncture/Hole1
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.
MalfunctionOct 19, 2021Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation
IT WAS REPORTED THAT A VENTRICULAR CATHETER LOOSE CSF LIQUID, SEEMS TO BE PERFORATED BEFORE SURGERY. A DELAY OF MORE THAN 15 MINUTES IN SURGERY OCCURRED. THE VENTRICULAR CATHETER IS A PART OF THE LOT 20049548 (FX597T) PROGAV 2.0 SHUNTSYSTEM ((B)(4)). NO PATIENT INFORMATION WERE SUBMITTED.
Patient problems: Hydrocephalus
MAUDE report 12657728 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page