AESCULAP FV039TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · BURR HOLE RESERVOIR PED · 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 04041906116408), received between Nov 22, 2022 and Nov 1, 2023 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Mechanical Problem1
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.
InjuryNov 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDI BOHRLOCHRESERVOIR (#FV039T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(4) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE AND BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(4) 2023. 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: 2 YEARS, 6 MONTHS, WEIGHT: 10.4 KILOGRAMS, HEIGHT: 82.7 CENTIMETERS, GENDER: MALE, SAME EVENT AS # 3004721439-2023-00311, AND # 3004721439-2023-00313.
Patient problems: Hydrocephalus
MAUDE report 18049306 ↗InjuryAug 14, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A BURR HOLE RESERVOIR (#FV039T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE RESERVOIR CAUSED AN UNDERDRAINAGE IN COMBINATION WITH A PROGAV 2.0 SHUNTSYSTEM. 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. AGE: 5 YEARS, 8 MONTHS, HEIGHT: 105 CENTIMETERS (CM), WEIGHT: 17 KILOGRAMS (KG), GENDER: MALE. SAME INCIDENT AS MEDWATCH# 3004721439-2023-00234.
Patient problems: Hydrocephalus
MAUDE report 17541113 ↗InjuryNov 22, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PEDIATRIC BURRHOLE RESERVOIR (PART # FV039T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE RESERVOIR WAS BELIEVED TO HAVE ADJUSTMENT DIFFICULTIES, HOWEVER A RESERVOIR IS NOT ADJUSTABLE. 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# 3004721439-2022-00359.
Patient problems: Hydrocephalus
MAUDE report 15848427 ↗
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- 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
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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 13, 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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