PROGAV 2.0 FX550TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906503154), received between Mar 20, 2024 and Mar 18, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX551T) WHICH IS PART OF A SAMPLE ACCOUNT FROM AN US SALES REPRESENTATIVE HAD ADJUSTMENT DIFFICULTIES. NO PATIENT COMPLICATIONS WERE REPORTED AS NO PATIENT WAS INVOLVED. THE COMPLAINED DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634549 ↗
• MalfunctionNov 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX550T) WAS WAS UNABLE TO PROGRAM PRIOR USE. THE INCIDENT CONTRIBUTE A DELAY OF THE SURGERY (5 MINUTES). NO PATIENT COMPLICATIONS WERE REPORTED. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463428 ↗
• MalfunctionOct 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX550T) HAD ADJUSTMENT DIFFICULTIES PREOPERATIVELY. THE PRODUCT WAS NOT IMPLANTED. NO PATIENT COMPLICATION WERE REPORTED. THE COMPLAINED PRODUCT WWILL BE RETURN TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 23254572 ↗
• InjuryMar 20, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYS SA2.0 15 & CONTROL RES. (PART # FX550T) WAS IMPLANTED DURING A REVISION SURGERY ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE SHUNT SETTING WAS AT 10. REPORTEDLY THE PATIENT UNDERWENT A SHUNT STUDY ON (B)(6) 2023 THAT WAS REPORTED TO BE SUCCESSFUL. DURING THIS TIME THE PATIENT ALSO UNDERWENT A CERVICAL SPINE MRI ON (B)(6) 2023 AND A BRAIN MRI ON (B)(6) 2023. THE PATIENT WENT TO AN OUTSIDE HOSPITAL ON (B)(6) 2023 WITH HEADACHES WHERE THE SHUNT WAS CHECKED AND REPORTED TO BE AT A SETTING OF 2. THIS WAS THEN CHANGED BACK TO 10. ON (B)(6) 2024 THE PATIENT RETURNED TO THE ORIGINAL CLINIC DUE TOT HIGH PRESSURE SYMPTOMS. AN X-RAY WAS PERFORMED AND THE VALVE WAS FOUND TO BE SET AT 9. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO A DEVICE FROM ANOTHER SUPPLIER. TESTING IMMEDIATELY PRIOR TO REMOVAL REVEALED THE SHUNT TO BE SET AT 10 WITH THE PROGRAMMER DEVICE. NO ATTEMPTS TO CHANGE THE SHUNT WERE MADE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 18939506 ↗
• InjuryMar 20, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX550T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT PROBLEMS. 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: 34 YEARS, 6 MONTHS. WEIGHT: 87 KG. HEIGHT: 170 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18939504 ↗