AESCULAPRecalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 18 models of AESCULAP by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2020 and Dec 5, 2025 — classified as 52 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AESCULAP problems
Device problems
- Infusion or Flow Problem33
- Mechanical Problem10
- Obstruction of Flow4
- Break3
- Insufficient Device Problem Information3
- Complete Blockage2
- Material Integrity Problem2
- Microbial Contamination of Device2
Patient problems
- Hydrocephalus52
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
AESCULAP models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AESCULAP FV035TShunt, central nervous system and components10 reports
- AESCULAP FV046TShunt, central nervous system and components8 reports
- AESCULAP FV049TShunt, central nervous system and components6 reports
- AESCULAP FV100TShunt, central nervous system and components5 reports
- AESCULAP FV128TShunt, central nervous system and components3 reports
- AESCULAP FV173TShunt, central nervous system and components3 reports
- AESCULAP FV298TShunt, central nervous system and components3 reports
- AESCULAP FV039TShunt, central nervous system and components3 reports
- AESCULAP FV072PShunt, central nervous system and components3 reports
- AESCULAP FV077PCATHETER, VENTRICULAR2 reports
- AESCULAP FV043TShunt, central nervous system and components2 reports
- AESCULAP FV027TShunt, central nervous system and components1 report
- AESCULAP FV012TShunt, central nervous system and components1 report
- AESCULAP FV078PShunt, central nervous system and components1 report
- AESCULAP FV079TShunt, central nervous system and components1 report
- AESCULAP FV044TShunt, central nervous system and components1 report
- AESCULAP FV047TShunt, central nervous system and components1 report
- AESCULAP FV048TShunt, central nervous system and components1 report
Recent AESCULAP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DSV VALVE (#FV119T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23726572 ↗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 ↗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 ↗InjuryJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CONTROL RESERVOIR SET WITH DISTAL. CATHETER (#FV049T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SYSTEM CAUSED A MALFUNCTION. THE PATIENT UNDERWENT ANOTHER SURGERY, BUT THE SYSTEM WAS NOT REMOVED BECAUSE THE CATHETER HAD GROWN INTO THE TISSUE. HOWEVER, A NEW SYSTEM WAS ADDITIONALLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE SURGERY PROCEDURE. THE COMPLAINED PRODUCT WAS NOT SENT TO THE MANUFACTURER BECAUSE IT IS STILL IMPLANTED. SAME EVENT AS # 3004721439-2025-00206.
Patient problems: Hydrocephalus
MAUDE report 22554263 ↗InjuryJul 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DUALSWITCHVALVE (DSV) (#FV100T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22470957 ↗InjuryMay 15, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A DSV VALVE (#FV128T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22030197 ↗InjuryDec 9, 2024Obstruction of Flow; Obstruction of Flow
THE DEVICE HAS NOW BEEN SENT IN AND COULD BE INVESTIGATED BY US. SAME INCIDENT AS MEDWATCH 3004721439-2024-00375.
Patient problems: Hydrocephalus
MAUDE report 20877634 ↗InjuryOct 11, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (REGARDING MEDWATCH FORM (B)(4)) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. THE SPRUNG RESERVOIR SET (FV046T) FROM THIS REPORT WAS SUBSEQUENTLY CONNECTED TO THE ABOVEMENTIONED PROGAV 2.0 SHUNTSYSTEM BY THE HOSPITAL. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 37 YEARS. HEIGHT: 150 CM. WEIGHT: 48 KG. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20426835 ↗InjuryOct 10, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A CONNECTOR STRAIGHT (#FV012T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PRODUCT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 74 YEARS. WEIGHT: 60 KGS. HEIGHT: 150 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00309.
Patient problems: Hydrocephalus
MAUDE report 20422261 ↗InjurySep 18, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SPRUNR RESERVOIR (#FV146T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 54 YEARS. WEIGHT: 107 KGS. HEIGHT: 179 CM. GENDER: MALE. SAME EVENT AS # REPORTED HEREIN.
Patient problems: Hydrocephalus
MAUDE report 20245659 ↗InjurySep 16, 2024Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn
THE DEVICE (PART OF #(B)(6) - VENTRICULAR CATHETER) WAS RETURNED TO THE MANUFACTURER FOR EXAMINATION.
Patient problems: Hydrocephalus
MAUDE report 20225140 ↗InjuryJul 3, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PED. PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PRECHMABER CAUSED AN OCCLUSION. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 2 YEARS, 6 MONTHS. HEIGHT: 87 CM. WEIGHT: 11 KG. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19670536 ↗InjuryMay 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SPRUNG RESERVOIR-SET (# FV046T) WAS IMPLANTED DURING A REVISION PROCEDURE (MEDWATCH#3 004721439-2024-00120) PERFORMED ON (B)(6) 2024. THE SPRUNG RESERVOIR WAS IMPLANTED TOGETHER WITH # FX418T (MEDWATCH#3004721439-2024-00135). ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 MONTHS HEIGHT: 64 CM WEIGHT: 9 KG GENDER: MALE SAME INCIDENT/PATIENT AS MEDWATCH# 3004721439-2024-00135
Patient problems: Hydrocephalus
MAUDE report 19405675 ↗InjuryMay 1, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PEDIATRIC PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PRECHAMBER CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 5 MONTHS, HEIGHT: 56 CM, WEIGHT: 4.95 KG, GENDER: MALE. SAME EVENT AS MEDWATCH#: 3004721439-2024-00106 + MEDWATCH#: 3004721439-2024-00107.
Patient problems: Hydrocephalus
MAUDE report 19225917 ↗InjuryMar 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SPRUNG RESERVOIR (#FV046T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD A LEAK FROM THE CATHETER ON THE DISTAL SIDE OF THE RESERVOIR. THE RESERVOIR WAS EXPLANTED AGAIN. THE COMPLAINANT'S DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 18967886 ↗
Other Christoph Miethke GmbH & Co. KG products
All Christoph Miethke GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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