proGAV® FV448TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906132682), received between Jan 26, 2021 and Apr 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV448T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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: 14 YEARS. HEIGHT: 150.5 CM. WEIGHT: 45 KG. GENDER: FEMALE. SAME EVENT AS MEDWATCH# 3004721439-2024-00084.

  Patient problems: Hydrocephalus

  MAUDE report 19086828 ↗
• InjuryFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE ABDOMINAL CATHETER IS RUPTURED BEHIND THE SHUNT. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS CONNECTED AND IMPLANTED. THE SHUNT SYSTEM IS STILL IMPLANTED. A PART OF THE COMPLAINED CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS, 9 MONTHS. HEIGHT: 103.5 CM. WEIGHT: 16 KG. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18762663 ↗
• InjuryNov 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (PART # FV448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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. AGE: 12 YEARS AND 3 MONTHS. HEIGHT: 165 CENTIMETERS (CM). WEIGHT: 61 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15849820 ↗
• InjuryMar 29, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), HEIGHT: 160 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 13944001 ↗
• InjuryDec 3, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV OPERATED IN OVERDRAINAGE POSTOPERATIVELY . THE VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 120 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12927878 ↗
• InjuryOct 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV448T - PROGAV SYS PED.W/SA 20 A.BURRH.RES. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OVERDRAINAGE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12627632 ↗
• InjuryOct 6, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.BURRH.RES. (PART # FV448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF OPERATING IN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: 149 CENTIMETERS (CM) GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12586803 ↗
• InjuryJan 26, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  INVESTIGATION COMPLETED.

  Patient problems: Hydrocephalus

  MAUDE report 11230022 ↗