proGAV 2.0® FX420TRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04041906136628), received between Apr 9, 2021 and Sep 5, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV251T) WAS IMPLANTED TOGETHER WITH A PROGAV 2.0 SHUNTSYSTEM (FX#431-T) DURING A PROCEDURE ON (B)(6) 2024. SOME ADJUSTMENTS OF THE PROGAV 2.0 WERE PERFORMED. ON (B)(6) 2025 THE PATIENT CAME IN THE HOSPITAL FOR REVIEW AND NEEDED AN ADJUSTMENT. THE CHANGE OF THE PRESSURE SETTING WAS NOT POSSIBLE. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025 OF BOTH PRODUCTS. THE REVISED PRODUCTS WERE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH 3004721439-2025-00262 (#FX431-T).

  Patient problems: Hydrocephalus

  MAUDE report 22976818 ↗
• InjuryJul 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT ANOTHER SURGERY, BUT THE SYSTEM WAS NOT REMOVED BECAUSE THE CATHETER HAD GROWN INTO THE TISSUE. HOWEVER, A NEW SYSTEM WAS ADDITIONALLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE SURGERY PROCEDURE. THE COMPLAINED PRODUCT WAS NOT SENT TO THE MANUFACTURER BECAUSE IT IST STLL IMPLANTED. SAME EVENT AS # 3004721439-2025-00205.

  Patient problems: Hydrocephalus

  MAUDE report 22554264 ↗
• InjuryDec 27, 2024Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21026911 ↗
• InjuryDec 9, 2024Obstruction of Flow; Obstruction of Flow

  THE DEVICE HAS NOW BEEN SENT IN AND COULD BE INVESTIGATED BY US. SAME INCIDENT AS MEDWATCH 3004721439-2024-00376.

  Patient problems: Hydrocephalus

  MAUDE report 20877622 ↗
• InjuryOct 11, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 37 YEARS, HEIGHT: 150 CM, WEIGHT: 48 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 20426794 ↗
• InjuryJul 21, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART #FX420T) IN COMBINATION WITH A CONTROL RESERVOIR SET (PART #FV049T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE CATHETER OF THE SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WILL BE RETURN TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH#3004721439-2023-00197.

  Patient problems: Hydrocephalus

  MAUDE report 17375266 ↗
• InjuryOct 21, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH# 3004721439-2022-00319.

  Patient problems: Hydrocephalus

  MAUDE report 15654913 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX420T) WAS IMPLANTED DURING AN ABDOMINAL SHUNT SURGICAL PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. REPORTEDLY, A POST OPERATIVE RE-EXAMINATION FOUND THAT THE PATIENT'S CEREBROSPINAL FLUID WAS NOT ABLE TO BE SHUNTED OUT. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS MEDWATCH # 3004721439-2022-00259.

  Patient problems: Hydrocephalus

  MAUDE report 15320476 ↗
• MalfunctionAug 19, 2022Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Incomplete or Missing Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  IT WAS REPORTED IN ACCORDANCE TO THE COMPLAINANT, THE PROGAV 2.0 SHUNT SYSTEM (#FX420T) WAS PACKAGED ONLY IN ONE STERILE PACKAGING. HOWEVER, THE SURGEON USED THE DEVICE BECAUSE, THEY GET THE INFORMATION THAT IT WAS JUDGED TO BE STERILISED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 15261572 ↗
• InjuryMar 2, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED AND WAS UNABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 13655965 ↗
• InjuryDec 23, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX420T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6). HEIGHT: 150 CM. WEIGHT: (B)(6). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13078127 ↗
• InjuryDec 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV 2.0 WITH SA20 AND DISTAL CATHETER (PART # FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE FV046 AND FX420T WERE IMPLANTED DURING THE PRIMARY SURGERY WITH AN INITIAL VALUE OF 5CMH20. THE DAY AFTER THE PRIMARY SURGERY, OVER-DRAINAGE WAS OBSERVED. THE PRESSURE VALUE WAS RE-ADJUSTED UP TO 18CMH20 TO COPE WITH OVER-DRAINAGE, AND THE PATIENT'S CONDITION IMPROVED. HOWEVER, VENTRICULAR ENLARGEMENT WAS OBSERVED AS A RESULT OF THE ELEVATED OPENING PRESSURE, AND THE VALVE WAS RE-ADJUSTED DOWN TO 2 CMH20 ON STEP BY STEP BASIS. BY DECREASING THE OPENING PRESSURE, THE PATIENT EXHIBITED OVER-DRAINAGE SYMPTOMS AND BY ELEVATING THE PRESSURE, UNDER-DRAINAGE SYMPTOMS OCCURRED. SHUNT RADIOGRAPH REVEALED NO OBSTRUCTION OF THE SHUNT PATHWAY. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 TO REMOVE ONLY THE GRAVITATIONAL VALVE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: UNKNOWN, WEIGHT: (B)(6), HEIGHT: 180 CENTIMETERS (CM), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12957134 ↗
• InjuryNov 1, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 WITH SA20 AND DISTAL CATHETER (#FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. HEIGHT : 102 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12730200 ↗
• InjuryOct 20, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM(#FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021 INDWELLED BY POSTERIOR PUNCTURE . ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINANT DEVICE SHOULD BE RETURN TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6)YEARS, HEIGHT: 168 CM, WEIGHT: (B)(6) KG, GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12666631 ↗
• InjuryOct 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (# FX420T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE EVENT DATE WAS NOTED AS (B)(6) 2021. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) YEARS, HEIGHT: UNKNOWN, WEIGHT: UNKNOWN, GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12657731 ↗
• InjuryOct 5, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD A MALFUNCTION POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNSPECIFIED DATE. THE PRODUCT WAS EXPLANTED SINCE ATTEMPTS TO RE-ADJUST THE VALVE WERE UNSUCCESSFUL (UNABLE TO SET THE OPENING PRESSURE TO A LOWER VALUE), AND RETURNED TO THE MANUFACTURER FOR EVALUATION. THE EVENT DATE WAS NOTED AS (B)(6) 2016. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12577914 ↗
• InjuryJul 1, 2021Infusion or Flow Problem; Infusion or Flow Problem

  INVESTIGATION IS COMPLETED.

  Patient problems: Hydrocephalus

  MAUDE report 12100297 ↗
• InjuryApr 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 VALVE WAS FOUND TO BE DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATIONS: AGE: (B)(6) YEARS GENDER: FEMALE. SAME PATIENT/EVENT: MEDWATCH#3004721439-2021-00074.

  Patient problems: Hydrocephalus

  MAUDE report 11644819 ↗