PROGAV 2.0 FX642TRecalls & reported problems
Aesculap AG · PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20 · Class 2 · Implant
Quick summary
This Aesculap proGAV 2.0 adjustable shunt is implanted in the head to drain fluid for patients with hydrocephalus. Most of the 57 reports describe drainage problems — fluid moving too little or too much, a valve that sticks or resists, and trouble adjusting it — in patients who then needed a revision surgery;52 reports describe injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 04041906502003), received between Jan 26, 2021 and Aug 17, 2026 — classified as 52 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (30 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem30
- Mechanical Problem15
- Obstruction of Flow14
- Physical Resistance/Sticking14
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Excess Flow or Over-Infusion1
- Incomplete or Missing Packaging1
Patient problems
- Hydrocephalus55
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Obstruction of Flow
It was reported that a proGAV 2.0 Shuntsystem (#FX642T) was implanted on (b)(6) 2026.According to the complainant, the shunt system caused an underdrainage. The patient underwent a revision procedure on (b)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 50275393 ↗InjuryMay 22, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25260496 ↗InjuryMay 12, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX642T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25148022 ↗InjuryMay 12, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX642T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM/VALVE WAS UNABLE TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25147985 ↗InjuryMay 12, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25147881 ↗InjuryMay 4, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25070920 ↗InjuryApr 20, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 WITH SHUNTASSISTANT 2.0 (20) (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24928070 ↗InjuryJan 26, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24177276 ↗InjuryJan 20, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24115194 ↗InjuryJan 12, 2026No Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 24035394 ↗InjuryDec 15, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 WITH A SHUNTASSISTANT 2.0 (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 23804382 ↗MalfunctionNov 24, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) SHOUD BE IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINGE/BLOCKAGE DURING SURGERY. ANOTHER SHUNT SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23631283 ↗MalfunctionNov 3, 2025Obstruction of Flow; Obstruction of Flow
THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23455753 ↗MalfunctionNov 3, 2025Obstruction of Flow; Obstruction of Flow
THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23455635 ↗InjuryOct 27, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNERDRAINAGE AND HAD ADJUSTMENT DIFICULTIES. 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 23391220 ↗InjuryOct 20, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23335243 ↗MalfunctionAug 11, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THE CUSTOMER FOUND THE SHUNT BOX EMPTY. ALL THE PAPERWORK IS THERE BUT SHUNT IS MISSING. NO PATIENT HARM OR DELAY IN THERAPY WAS REPORTED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773119 ↗InjuryAug 4, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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 22698315 ↗InjuryJul 28, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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.
Patient problems: Hydrocephalus
MAUDE report 22629019 ↗InjuryJul 3, 2025Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking; Obstruction of Flow; Insufficient Device Problem Information; Physical Resistance/Sticking
LIMITED INFORMATION - DETAILED PRODUCT DATA AND REASON FOR EXPLANTATION UNKNOWN NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22394158 ↗InjuryMar 10, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. 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.
Patient problems: Hydrocephalus
MAUDE report 21558564 ↗InjuryFeb 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21447959 ↗InjuryJan 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (# FX642T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 21242592 ↗InjuryDec 19, 2024Unintended System Motion; Unintended System Motion
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20 (PART# FX642T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT UPON ATTEMPTING TO REPROGRAM VALVE THE DEVICE WOULD NOT RESPOND TO ADJUSTMENT. THE VALVE IS STUCK AT 5. REPORTEDLY A REVISION IS PLANNED FOR SOMETIME AFTER THE 2024 HOLIDAY SEASON. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Failure of Implant
MAUDE report 20976498 ↗InjuryDec 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 (#FX642T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 20976496 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- 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
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.