proSA® FX992TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROSA WITH PROGAV 2.0 · Class 2 · Implant
All models of proSA (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906138431), received between Dec 5, 2017 and Jun 9, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (4 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.
Most reported problems
Device problems
- Mechanical Problem4
- Adverse Event Without Identified Device or Use Problem2
- Infusion or Flow Problem2
- Device Operates Differently Than Expected1
Patient problems
- Hydrocephalus8
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROSA WITH PROGAV 2.0 (#FX992T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 17100990 ↗InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PROSA WITH PROGAV 2.0 (PART # FX992T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PROSA SHUNTSYTEM WAS EXPLANTED DURING A REVISION PROCEDURE PERFORMED ON (B)(6) 2021. AT THIS TIME, NO MALFUNCTION HAS BEEN REPORTED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. IT´S THE SAME PATIENT AS #3004721439-2021-00310.
Patient problems: Hydrocephalus
MAUDE report 12824241 ↗InjuryAug 24, 2021Mechanical Problem; Mechanical Problem
SUSPICIAN OF OVER-DRAINAGE. THE PROSA WAS EXCHANGED TO AN MBLUE ZERO AND PATIENT IS DOING WELL.
Patient problems: Hydrocephalus
MAUDE report 12358828 ↗InjuryAug 23, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PROSA SHUNTSYSTEM WITH PROGAV 2.0 (FX992T) HAS A PROBLEM WITH THE ADJUSTABILITY. THE SURGEON CHANGED THE PROSA VALVE TO 24, AND X-RAY RESULTS CONFIRMED SETTING BUT PATIENT RETURNED 2 WEEKS LATER WITH SYMPTOMS (UNSPECIFIED). UPON CHECKING THE VALVE IT HAD CHANGED TO 36. THE SURGEON CHANGED IT BACK TO 24, AND CONFIRMED THE SETTING, BUT PATIENT CAME BACK AGAIN WITH VALVE MOVED. SURGEON THEN SCHEDULED PATIENT FOR REVISION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT DATA AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 12354650 ↗InjuryOct 28, 2020Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNTSYSTEM. THE REPORTER SUSPECTED AN OVERDRAINAGE. PATIENT INFORMATION: AGE: (B)(6) YEARS. WEIGHT: (B)(6) KG. HIGHT: 168 CM. GENDER: UNKNOWN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 10747870 ↗InjuryOct 27, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROSA SHUNT SYSTEM WITH PROGAV 2.0. THE VALVES ARE NOT ADJUSTABLE. PATIENT INFORMATION: AGE: (B)(6) YEARS. WEIGHT: (B)(6) KG. HEIGHT: 117 CM. GENDER: UNKNOWN. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REMOVAL: (B)(6) 2020.
Patient problems: Hydrocephalus
MAUDE report 10743775 ↗InjuryDec 5, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected
A COMPREHENSIVE REVIEW OF THE OPEN COMPLAINTS IN THE SYSTEM WAS PERFORMED. ALTHOUGH THIS EVENT WAS PROPERLY ASSESSED AND REPORTED, THE FOLLOW-UP WAS NOT SUBMITTED. THEREFORE, THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED SUBSEQUENTLY.
Patient problems: Hydrocephalus; No Known Impact Or Consequence To Patient
MAUDE report 7084745 ↗
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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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