proGAV 2.0® FX436TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS W/SA30 A.CONTROL RESERV. · Class 2 · Implant
All models of proGAV 2.0 (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906137342), received between Feb 4, 2021 and Dec 21, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Hydrocephalus2
- Headache1
- Incontinence1
- Meningitis1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX436T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT REPORTED THAT THE SKULL IS SWELLING ON BACK OF THE HEAD. THE FOLLOWING SYMPTOMS WERE REPORTED: CRANIAL HYPERTENSION, NEGATIVE PRESSURE ON THE SIDES, SWELLING, BLURRED MONOCULAR VISION AT A VERY HIGH LEVEL, SLURRED SPEECH, INBALANCE WHEN WALKING, URINARY INCONTINENCE AND LOSS OF RECENT MEMORY. HEADACHE. SOME MEDICATION MANEUVERS WERE PERFORMED TO ALLEVIATE THE SYMPTOMS. THE SURGERY WAS PERFORMED ON (B)(6)2023 AND A BENT OF THE CATHETER AND TOUCHING THE BLADDER WAS DETERMINED. PATIENT DATA: AGE: 31 YEARS HEIGHT: 182 CM WEIGHT: 118 KG GENDER: MALE.
Patient problems: Headache; Hydrocephalus; Incontinence; Meningitis; Swelling/ Edema
MAUDE report 18371733 ↗InjuryFeb 4, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0 VALVE. THE SURGEON SUSPECTED A DYSFUNCTION/BLOCKAGE OF THE VALVE. PATIENT INFORMATIONS: (B)(6).
Patient problems: Hydrocephalus
MAUDE report 11280521 ↗
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- 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
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- 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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