AESCULAP FV049TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · CONTROLRESERVOIR SET W/DISTAL CATHETER · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906131487), received between Aug 30, 2022 and Jul 21, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem4
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- Hydrocephalus6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryNov 3, 2023Infusion or Flow Problem; Infusion or Flow Problem
E-SUBMITTER. IT WAS REPORTED THAT A CONTROL RESERVOIR (#FV049T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. 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: UNKNOWN. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 18065964 ↗InjuryJul 21, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A CONTROL RESERVOIR SET (PART#: FV049T) IN COMBINATION WITH A PROGAV 2.0 (PART#: FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE CATHETER OF THE SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WILL BE RETURN TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH#: 3004721439-2023-00198.
Patient problems: Hydrocephalus
MAUDE report 17375265 ↗InjuryOct 21, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A CONTROL RESERVOIR (PARTT # FV049T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE RESERVOIR WAS BELIEVED TO BE BLOCKED. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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. SAME EVENT AS MEDWATCH# 3004721439-2022-00320.
Patient problems: Hydrocephalus
MAUDE report 15654987 ↗InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A CONTROL RESERVOIR (PART # FV049T) WAS IMPLANTED DURING AN ABDOMINAL SHUNT SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. REPORTEDLY, A POST OPERATIVE RE-EXAMINATION FOUND THAT THE PATIENT'S CEREBROSPINAL FLUID WAS NOT ABLE TO BE SHUNTED OUT. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH # 3004721439-2022-00258.
Patient problems: Hydrocephalus
MAUDE report 15320475 ↗
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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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