proGAV 2.0® FX471TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES · Class 2 · Implant
All models of proGAV 2.0 (49)
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 04041906138165), received between Dec 8, 2021 and Mar 31, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 Problem3
- Physical Resistance/Sticking2
- Insufficient Device Problem Information1
- Mechanical Problem1
- Unintended System Motion1
Patient problems
- Hydrocephalus5
- Failure of Implant1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 (#FX471T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE (REPORTED DATE OF IMPLANTATION AND PRODUCTION DATE OF THE USED VALVE DO NOT ALIGN). ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AFTER RECEIVING THE PRODUCT WE DISCOVERED THAT AN M. BLUE HAD BEEN EXPLANTED AS WELL, OF WHICH WE WERE PREVIOUSLY UNAWARE. SAME EVENT AS THIS CASE, RUNS AS RM 5488_1 / 400704081 / 3004721439-2025-00101.
Patient problems: Hydrocephalus
MAUDE report 21729950 ↗InjuryDec 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 (#FX471T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT VALVE HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT HAS BEEN SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 20976666 ↗InjuryDec 19, 2024Unintended System Motion; Unintended System Motion
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYS PED.W/SA20 A. BURRHOLE RES (PART# FX471T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE DEVICE WAS NOT KEEPING PRESSURE SETTINGS. EVERY TIME THE PATIENT CAME IN TO THE CLINIC THE PRESSURE WAS DIFFERENT THAN WHEN HE LEFT CLINIC PREVIOUSLY. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Failure of Implant
MAUDE report 20976547 ↗InjuryJul 27, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX471T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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-NO.: 3004721439-2022-00118 AND 3004721439-2022-00119.
Patient problems: Hydrocephalus
MAUDE report 15112437 ↗InjuryMay 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PROSA (PART # UNKNOWN) AND PROGAV 2.0 (PART # UNKNOWN) WERE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. SAME EVENT AS MEDWATCH MDR ID # 3004721439-2022-00127.
Patient problems: Hydrocephalus
MAUDE report 14269652 ↗InjuryDec 8, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
AGE: 5 YEARS; WEIGHT: 20.8 KILOGRAMS (KG); HEIGHT: 78 CENTIMETERS (CM); GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 12960364 ↗
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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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