AESCULAP FV043TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · SPRUNG RESERVOIR · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04041906131364), received between Jun 6, 2023 and Jun 6, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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.
Most reported problems
Device problems
- Infusion or Flow Problem2
Patient problems
- Hydrocephalus1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED TO AESCULAP INC. THAT A SPRUNG RESERVOIR (PRODUCT # FV043T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM (SPRUNG RESERVOIR + M.BLUE) SHOWED A DRAINAGE PROBLEM. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORT # 2916714-2023-00068.
Patient problems: Insufficient Information
MAUDE report 17073531 ↗InjuryJun 6, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SPRUNG RESERVOIR (#FV043T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM (SPRUNG RESERVOIR + M.BLUE) SHOWED A DRAINAGE PROBLEM. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE RELEASE FOR INVESTIGATION IS MISSING, SO THE EXAMINATION COULD NOT BE STARTED. SAME EVENT AS MEDWATCH #3004721439-2023-00171.
Patient problems: Hydrocephalus
MAUDE report 17072148 ↗
Other Shunt, central nervous system and components devices
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- 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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