proSARecalls & reported problems across all models
Christoph Miethke GmbH & Co. KG · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 142
- Deaths reported
- 0
- Injuries reported
- 135
- Recalls
- 0
We found 17 models of proSA by Christoph Miethke GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 142 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and Jan 20, 2026 — classified as 135 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (103 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 proSA problems
Device problems
- Infusion or Flow Problem103
- Mechanical Problem72
- Insufficient Device Problem Information4
- Physical Resistance/Sticking4
- Adverse Event Without Identified Device or Use Problem2
- Obstruction of Flow2
- Device Damaged Prior to Use1
- Device Operates Differently Than Expected1
Patient problems
- Hydrocephalus139
- Headache2
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- Visual Impairment1
proSA models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- proSA® FV701TShunt, central nervous system and components82 reports
- proSA® FV770TShunt, central nervous system and components15 reports
- proSA® FX991TShunt, central nervous system and components11 reports
- proSA® FX992TShunt, central nervous system and components8 reports
- proSA® FV713TShunt, central nervous system and components6 reports
- proSA® FV708TShunt, central nervous system and components3 reports
- proSA® FV703TShunt, central nervous system and components2 reports
- proSA® FV706TShunt, central nervous system and components2 reports
- proSA® FV707TShunt, central nervous system and components2 reports
- proSA® FV709TShunt, central nervous system and components2 reports
- proSA® FX993TShunt, central nervous system and components2 reports
- proSA® FV785TShunt, central nervous system and components2 reports
- proSA® FV702TShunt, central nervous system and components1 report
- proSA® FV723TShunt, central nervous system and components1 report
- proSA® FV728TShunt, central nervous system and components1 report
- proSA® FX998TShunt, central nervous system and components1 report
- proSA® FX995TShunt, central nervous system and components1 report
Recent proSA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Obstruction of Flow
IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT CAUSED AN UNDERDRAINAGE. 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. SAME EVENT/ PATIENT AS # 3004721439-2026-00013.
Patient problems: Hydrocephalus
MAUDE report 24114901 ↗InjuryOct 22, 2025Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED 10 YEARS AGO. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23358451 ↗InjuryOct 20, 2025Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT THE PATIENT WAS IMPLANTED WITH A PROSA VALVE 10 YEARS AGO. REPORTEDLY THE SURGEON RECENTLY HAD TO DO A SHUNT REVISION AND IT APPEARED THE PROSA WASN'T WORKING SO THE SURGEON EXPLANTED THE VALVE AND WANTS TO SEND IT TO FOR TESTING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 23341380 ↗InjuryJul 11, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. 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 # 3004721439-2025-00188.
Patient problems: Hydrocephalus
MAUDE report 22478042 ↗InjuryFeb 24, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE 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 21447712 ↗InjuryFeb 24, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. (IMPLANTATION DATE, ACCORDING TO QUESTIONNAIRE, IS BEFORE PRODUCTION DATE) ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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. SAME EVENT AS # 3004721439-2025-00038.
Patient problems: Hydrocephalus
MAUDE report 21446677 ↗InjuryDec 9, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROSA SHUNTSYSTEM (#FX991T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 20877998 ↗InjurySep 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROSA (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 15 YEARS WEIGHT: 33 KGS HEIGHT: 141 CM GENDER: MALE SAME EVENT AS # 3004721439-2024-00299.
Patient problems: Hydrocephalus
MAUDE report 20320877 ↗InjurySep 18, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 16 YEARS WEIGHT: 53 KGS HEIGHT: 170 CM GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20245585 ↗InjuryAug 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROSA SHUNT SYSTEM (#FX995T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEARS, 4 MONTHS. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20054017 ↗MalfunctionAug 22, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE STERILIZATION PACKAGING HAD A POOR SEALING WHEN UNPACKING AND REFUSED TO USE THE DEVICE. THE DEVICE/PACKAGING WAS NOT RETURNED TO THE MANUFACTURER. PICTURES WITH THE PROBLEM WAS SUBMITTED.
Patient problems: Hydrocephalus
MAUDE report 20030805 ↗InjuryJul 17, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROSA VALVE (#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2013. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 11 YEARS, 3 MONTHS. WEIGHT: 36 KGS. HEIGHT: 152 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00193.
Patient problems: Hydrocephalus
MAUDE report 19760304 ↗InjuryJul 8, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROSA® (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2015. ACCORDING TO THE COMPLAINANT, THE PROSA VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN(B)(6) 2024; HOWEVER, THE EXACT DATE WAS NOT PROVIDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 19696356 ↗InjuryJun 6, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROSA® (PART # FV770T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2015. ACCORDING TO THE COMPLAINANT, THE PROSA VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024; HOWEVER, THE EXACT DATE WAS NOT PROVIDED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 19478397 ↗InjuryMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN IMPLANTED PROSA SHUNT SYSTEM (# FV770T), ACCORDINGLY TO THE COMPLAINANT, SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 21 YEARS. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19335157 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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