AESCULAP FV072PRecalls & reported problems
Christoph Miethke GmbH & Co. KG · Peritoneal Catheter (1200 mm), inner diam. 1,20 mm, outer diam. 2,50 mm, silicone, sterile, disposable · 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 04041906119904), received between Feb 9, 2022 and Sep 10, 2025 — classified as 3 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. 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
- Adverse Event Without Identified Device or Use Problem1
- Infusion or Flow Problem1
- Microbial Contamination of Device1
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.
InjurySep 10, 2025Microbial Contamination of Device; Microbial Contamination of Device
CUSTOMER REPORTED A CASE OF INFECTION WITH A PERITONEAL CATHTER (#FV072P) NO PATIENT DATA AVAILABLE. NO PATIENT HARM REPORTED. SAME EVENT AS #3004721439-2025-00258, #3004721439-2025-00260.
Patient problems: Hydrocephalus
MAUDE report 23017711 ↗InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT EXPLANTATION OCCURRED DUE TO A SUSPICION OF ALLERGIC REACTION TO THE PERITONEAL CATHETER (SILICONE). THE SURGEON INQUIRED THE MANUFACTURER IF THERE HAD BEEN ANY PREVIOUS CASES. IT WAS ALSO INQUIRED ABOUT THE COMPOSITION OF THE SILICONE CATHETERS SO THAT ALLERGY TESTING COULD BE PERFORMED IN THE DERMATOLOGY DEPARTMENT. THE CATHETER WAS IMPLANTED FOR APPROXIMATELY ONE (1) YEAR AND SIX (6) MONTHS WITHOUT ISSUE.
Patient problems: Hydrocephalus
MAUDE report 17375177 ↗InjuryFeb 9, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PERITONEAL CATHETER (PART # FV072P) 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 3004721439-2022-00014
Patient problems: Hydrocephalus
MAUDE report 13502098 ↗
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.
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