proGAV 2.0Recalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 49 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 544
- Deaths reported
- 1
- Injuries reported
- 522
- Recalls
- 0
We found 49 models of proGAV 2.0 by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 544 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2018 and Sep 28, 2026 — classified as 1 death, 522 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (337 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 Problem337
- Mechanical Problem230
- Obstruction of Flow60
- Physical Resistance/Sticking52
- Insufficient Device Problem Information14
- Adverse Event Without Identified Device or Use Problem4
- Loss of or Failure to Bond4
- Break3
Patient problems
- Hydrocephalus518
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions8
- Failure of Implant6
- Headache5
- Confusion/ Disorientation2
- Cyst(s)2
- Head Injury2
proGAV 2.0 models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- proGAV 2.0® FX410TShunt, central nervous system and components119 reports
- proGAV 2.0® FX441TShunt, central nervous system and components1 death63 reports
- proGAV 2.0® FX413TShunt, central nervous system and components57 reports
- proGAV 2.0® FX414TShunt, central nervous system and components49 reports
- proGAV 2.0® FX420TShunt, central nervous system and components18 reports
- proGAV 2.0® FX431TShunt, central nervous system and components15 reports
- proGAV 2.0® FX434TShunt, central nervous system and components14 reports
- proGAV 2.0® FX417TShunt, central nervous system and components13 reports
- proGAV 2.0® FX352TShunt, central nervous system and components13 reports
- proGAV 2.0® FX421TShunt, central nervous system and components12 reports
- proGAV 2.0® FX448TShunt, central nervous system and components12 reports
- proGAV 2.0® FX415TShunt, central nervous system and components11 reports
- proGAV 2.0® FX428TShunt, central nervous system and components11 reports
- proGAV 2.0® FX433TShunt, central nervous system and components11 reports
- proGAV 2.0® FX424TShunt, central nervous system and components10 reports
- proGAV 2.0® FX435TShunt, central nervous system and components10 reports
- proGAV 2.0® FX427TShunt, central nervous system and components8 reports
- proGAV 2.0® FX438TShunt, central nervous system and components8 reports
- proGAV 2.0® FX490TShunt, central nervous system and components8 reports
- proGAV 2.0® FX425TShunt, central nervous system and components7 reports
- proGAV 2.0® FX442TShunt, central nervous system and components7 reports
- proGAV 2.0® FX426TShunt, central nervous system and components6 reports
- proGAV 2.0® FX467TShunt, central nervous system and components6 reports
- proGAV 2.0® FX471TShunt, central nervous system and components6 reports
- proGAV 2.0® FX419TShunt, central nervous system and components5 reports
- proGAV 2.0® FX432TShunt, central nervous system and components5 reports
- proGAV 2.0® FX418TShunt, central nervous system and components4 reports
- proGAV 2.0® FX466TShunt, central nervous system and components4 reports
- proGAV 2.0® FX411TShunt, central nervous system and components3 reports
- proGAV 2.0® FX449TShunt, central nervous system and components3 reports
- proGAV 2.0® FX412TShunt, central nervous system and components2 reports
- proGAV 2.0® FX436TShunt, central nervous system and components2 reports
- proGAV 2.0® FX440TShunt, central nervous system and components2 reports
- proGAV 2.0® FX502TShunt, central nervous system and components2 reports
- proGAV 2.0® FX349TShunt, central nervous system and components2 reports
- proGAV 2.0® FX350TShunt, central nervous system and components2 reports
- proGAV 2.0® FX351TShunt, central nervous system and components2 reports
- proGAV 2.0® FX416TShunt, central nervous system and components1 report
- proGAV 2.0® FX525TShunt, central nervous system and components1 report
- proGAV 2.0® FX478TShunt, central nervous system and components1 report
- proGAV 2.0® FX479TShunt, central nervous system and components1 report
- proGAV 2.0® FX462TShunt, central nervous system and components1 report
- proGAV 2.0® FX463TShunt, central nervous system and components1 report
- proGAV 2.0® FX439TShunt, central nervous system and components1 report
- proGAV 2.0® FX445TShunt, central nervous system and components1 report
- proGAV 2.0® FX468TShunt, central nervous system and components1 report
- proGAV 2.0® FX470TShunt, central nervous system and components1 report
- proGAV 2.0® FX353TShunt, central nervous system and components1 report
- proGAV 2.0® FX343TShunt, 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 28, 2026Infusion or Flow Problem
It was reported that a SHUNTASSISTANT 2.0 (#FX103T) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an over drainage.The patient underwent a revision procedure on (b)(6) 2026.Related to MedWatchNo: 3004721439-2026-00276.
Patient problems: Hydrocephalus
MAUDE report 50913391 ↗InjuryAug 21, 2026Physical Resistance/Sticking
It was reported that a proGAV 2.0 valve (#FX410T) was implanted on (b)(6) 2024.According to the complainant, the valve had adjustment difficulties. The patient underwent a revision procedure on (b)(6) 2026.The sample will be returned for examination.This report is filed under AIC reference (b)(4).
Patient problems: Hydrocephalus
MAUDE report 50379774 ↗InjuryJun 23, 2026Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 VALVE(#FX410T) WAS IMPLANTED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-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 25594699 ↗MalfunctionMay 22, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX433T) WANTED TO BE IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM APPEARS TO HAVE BECOME BLOCKED DURING THE PROCEDURE. AS A RESULT, THE SHUNT COULD NOT BE USED, AND AN ADDITIONAL SHUNT HAD TO BE USED TO COMPLETE THE PROCEDURE. THE EVENT WAS CONSIDERED NON-SERIOUS BY THE CLIENT. PATIENT RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260351 ↗InjuryMay 18, 2026Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED IN (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS # 3004721439-2026-00142.
Patient problems: Hydrocephalus
MAUDE report 25200134 ↗InjuryMay 18, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 VALVE (#FX410T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON 04/14/2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS # 3004721439-2026-00135.
Patient problems: Hydrocephalus
MAUDE report 25200067 ↗MalfunctionMay 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A VETRICULAR CATHETER PART OF A PROGAV 2.0 SHUNT SYSTEM (#FX424T) TORE DURING PRE-SURGERY PREPARATIONS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070709 ↗InjuryApr 30, 2026Obstruction of Flow
ACCORDING TO THE EVENT DESCRIPTION: PATIENT HAD SEVERAL ED VISITS IN A 3-WEEK PERIOD FOR EPISODIC VOMITING, SOMNOLENCE, AND FULL/TENSE SUBGALEAL COLLECTION DUE TO SHUNT MALFUNCTION (WITH ENLARGED VENTRICLES). CONDITION IMPORVED TEMPORARILY TO SHUNT ADJUSTMENT. INTRA-OP FOUND TO HAVE VERY LITTLE FLOW THROUGH THE VALVE. THIS REPORT IS FILED UNDER AIC REFERENCE XC (B)(4) CC (B)(4)
Patient problems: Hydrocephalus; Sleepiness/Drowsiness/Somnolence; Vomiting
MAUDE report 25048696 ↗InjuryMar 30, 2026Obstruction of Flow; Calibration Problem
ACCORDING TO THE EVENT DESCRIPTION: URGENT SHUNT REVISION ON A 11 MONTH OLD MALE. THE VALVE SEEMED TO HAVE FLOW FOLLOWING EXPLANT BUT REQUIRED MANY OUTPATIENT ADJUSTMENTS. THE CLINICAL TEAM IS SUSPECTING OCCLUSION OR FAULTY MECHANISM AND REQUESTING ANALYSIS POST EXPLANT TO CONFIRM.
Patient problems: Hydrocephalus
MAUDE report 24715616 ↗InjuryMar 30, 2026Separation Problem
ACCORDING TO THE EVENT DESCRIPTION: PROGAV VALVE MR BREAK DOESN'T SEEM TO BE WORKING APPROPRIATELY. IT FEELS LIKE IT IS STICKING AND NOT AS SMOOTH AS IT USUALLY IS. THIS IS MAKING IT CHALLENGING TO REPROGRAM THE VALVE. VALVE IS BEING EXPLANTED AND REVISED.
Patient problems: Hydrocephalus
MAUDE report 24714764 ↗MalfunctionMar 23, 2026Mechanical Problem
IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV424T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE RESERVOIR COULD NOT BE PRIMED AND PRESSED. 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 24662273 ↗InjuryMar 9, 2026Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 24547110 ↗MalfunctionMar 9, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX352T) WAS BLOCKED PRE-IMPLANTATION. NO PATIENT INVOLVEMENT. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus; No Clinical Signs, Symptoms or Conditions
MAUDE report 24547109 ↗InjuryMar 9, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. SAME EVENT AS # 3004721439-2026-00056
Patient problems: Hydrocephalus
MAUDE report 24546400 ↗InjuryMar 9, 2026Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED TOGETHER WITH AN M.BLUE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVES CAUSED AN OVERDRAINAGE. 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 SAME EVENT AS MEDWATCH NO.: 3004721439-2026-00058.
Patient problems: Hydrocephalus
MAUDE report 24546192 ↗
Other Christoph Miethke GmbH & Co. KG products
All Christoph Miethke GmbH & Co. KG 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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