PROGAV 2.0Recalls & reported problems across all models
Aesculap AG · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 441
- Deaths reported
- 0
- Injuries reported
- 422
- Recalls
- 0
We found 43 models of PROGAV 2.0 by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 441 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2020 and Sep 14, 2026 — classified as 422 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (303 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 PROGAV 2.0 problems
Device problems
- Infusion or Flow Problem303
- Mechanical Problem139
- Obstruction of Flow76
- Physical Resistance/Sticking72
- Insufficient Device Problem Information12
- Adverse Event Without Identified Device or Use Problem5
- Excess Flow or Over-Infusion5
- Microbial Contamination of Device4
Patient problems
- Hydrocephalus430
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
- Failure of Implant1
PROGAV 2.0 models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROGAV 2.0 FX643TShunt, central nervous system and components100 reports
- PROGAV 2.0 FX642TShunt, central nervous system and components57 reports
- PROGAV 2.0 FX644TShunt, central nervous system and components33 reports
- PROGAV 2.0 FX603TShunt, central nervous system and components30 reports
- PROGAV 2.0 FX596TShunt, central nervous system and components30 reports
- PROGAV 2.0 FX597TShunt, central nervous system and components26 reports
- PROGAV 2.0 FX649TShunt, central nervous system and components19 reports
- PROGAV 2.0 FX602TShunt, central nervous system and components19 reports
- PROGAV 2.0 FX576TShunt, central nervous system and components16 reports
- PROGAV 2.0 FX571TShunt, central nervous system and components16 reports
- PROGAV 2.0 FX648TShunt, central nervous system and components11 reports
- PROGAV 2.0 FX577TShunt, central nervous system and components10 reports
- PROGAV 2.0 FX570TShunt, central nervous system and components9 reports
- PROGAV 2.0 FX673TShunt, central nervous system and components7 reports
- PROGAV 2.0 FX550TShunt, central nervous system and components5 reports
- PROGAV 2.0 FX385TShunt, central nervous system and components4 reports
- PROGAV 2.0 FX667TShunt, central nervous system and components4 reports
- PROGAV 2.0 FX647TShunt, central nervous system and components3 reports
- PROGAV 2.0 FX552TShunt, central nervous system and components3 reports
- PROGAV 2.0 FX594TShunt, central nervous system and components3 reports
- PROGAV 2.0 FX609TShunt, central nervous system and components3 reports
- PROGAV 2.0 FX640TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX641TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX650TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX684TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX384TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX574TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX564TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX666TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX554TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX661TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX583TShunt, central nervous system and components2 reports
- PROGAV 2.0 FX670TShunt, central nervous system and components1 report
- PROGAV 2.0 FX672TShunt, central nervous system and components1 report
- PROGAV 2.0 FX674TShunt, central nervous system and components1 report
- PROGAV 2.0 FX565TShunt, central nervous system and components1 report
- PROGAV 2.0 FX590TShunt, central nervous system and components1 report
- PROGAV 2.0 FX551TShunt, central nervous system and components1 report
- PROGAV 2.0 FX654TShunt, central nervous system and components1 report
- PROGAV 2.0 FX538TShunt, central nervous system and components1 report
- PROGAV 2.0 FX557TShunt, central nervous system and components1 report
- PROGAV 2.0 FX610TShunt, central nervous system and components1 report
- PROGAV 2.0 FX636TShunt, central nervous system and components1 report
Recent PROGAV 2.0 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Obstruction of Flow
It was reported that a proGAV 2.0 Shuntsystem (#FX596T) was implanted on (b)(6) 2020.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 50751990 ↗InjurySep 14, 2026Infusion or Flow Problem; Physical Resistance/Sticking
It was reported that a proGAV 2.0 Shuntsystem (#FX643T) was implanted on (b)(6) 2021.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 50751988 ↗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 ↗InjuryAug 13, 2026Insufficient Device Problem Information
It was reported that a PROGAV 2.0 WITH SA2.0 20 & PRECHAMBER (Part Number: FX654T) was implanted in a patient on an unspecified date in 2023. Reportedly during a clinical visit, the valve was unable to be reprogrammed. The device was explanted and replaced with an MBlue 10 valve.Additional information has been requested but not yet provided.This report is filed under AIC reference (b)(4).
Patient problems: Insufficient Information
MAUDE report 50235963 ↗InjuryAug 3, 2026Obstruction of Flow
It was reported that a proGAV 2.0 Shuntsystem (#FX603T) was implanted on 01/15/2024.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on 07/04/2026.No patient complications were reported as a result of the revision procedure.
Patient problems: Hydrocephalus
MAUDE report 50117879 ↗InjuryJul 27, 2026Obstruction of Flow
It was reported that a proGAV 2.0 shunt system(#FX643T) was implanted on (b)(6) 2026. 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 50038897 ↗InjuryJul 27, 2026Microbial Contamination of Device
It was reported that a proGAV 2.0 Shunt system (#FX597T) was implanted on (b)(6) 2026.According to the complainant, the procedure caused an infection.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 50038581 ↗InjuryJul 6, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM(#FX673T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVER-DRAINAGE 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.
Patient problems: Hydrocephalus
MAUDE report 25716414 ↗InjuryJul 6, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25716361 ↗InjuryJun 29, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX602T) WAS IMPLANTED 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.
Patient problems: Hydrocephalus
MAUDE report 25651289 ↗InjuryJun 15, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643X) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25505592 ↗InjuryJun 15, 2026Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX385T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 VALVE HAD UNINTENDED SHUNT ADJUSTMENT. 4 YEARS AGO, THE PATIENT HAVE A PREVIOUSLY SELF- ADJUSTED VALVE, TOO. THE NEUROSURGEON SUSPECTED THAT THE PATIENT ADJUSTED THE SHUNT HIMSELF. THE PATIENT UNDERWENT A REVISION PROCEDURE AND A NEW SINGLE PRESSURE VALVE WAS IMPLANTED. THE SHUNT IS STILL IN TRANSIT TO MANUFACTURER FOR EXAMINATION.
Patient problems: Hydrocephalus
MAUDE report 25505506 ↗InjuryMay 22, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVER-DRAINAGE 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.
Patient problems: Hydrocephalus
MAUDE report 25260546 ↗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 18, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX603T) WAS IMPLANTED ON (B)(6) 2025. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO REASON FOR THE EXPLANTATION WAS GIVEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25200180 ↗
Other Aesculap AG products
All Aesculap AG 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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