AESCULAP FV035TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04041906117603), received between Sep 17, 2020 and Jul 3, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PED. PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PRECHMABER CAUSED AN OCCLUSION. 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: 2 YEARS, 6 MONTHS. HEIGHT: 87 CM. WEIGHT: 11 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19670536 ↗
• InjuryMay 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PEDIATRIC PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PRECHAMBER CAUSED AN UNDERDRAINAGE. 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: 5 MONTHS, HEIGHT: 56 CM, WEIGHT: 4.95 KG, GENDER: MALE. SAME EVENT AS MEDWATCH#: 3004721439-2024-00106 + MEDWATCH#: 3004721439-2024-00107.

  Patient problems: Hydrocephalus

  MAUDE report 19225917 ↗
• InjuryMar 15, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PED.PRECHAMBER (#FV035T) AND A M.BLUE (#FXT802) WERE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PRECHAMBER CAUSED AN UNDERDRAINAGE. 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: 10 YEARS HEIGHT: 145 CM WEIGHT: 35 KG GENDER: FEMALE *SAME EVENT AS MEDWATCH#3004721439-2024-00067

  Patient problems: Hydrocephalus

  MAUDE report 18911942 ↗
• InjuryNov 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PAEDI PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE AND BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 2 YEARS, 6 MONTHS. WEIGHT: 10.4 KILOGRAMS. HEIGHT: 82.7 CENTIMETERS. GENDER: MALE. SAME EVENT AS # 3004721439-2023-00311 AND # 3004721439-2023-00312.

  Patient problems: Hydrocephalus

  MAUDE report 18049335 ↗
• InjuryJul 12, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PED. PRECHAMBER (PART # FV035T) WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE DYSFUNCTION. AGE: 16 YEARS, 11 MONTHS. HEIGHT: 150 CENTIMETERS (CM). WEIGHT: 40 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17312787 ↗
• InjuryAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PRECHAMBER PED. (PART # FV035T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. 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. PATIENT DATA: AGE: 8 MONTHS; WEIGHT: 5 KILOGRAMS (KG); HEIGHT: 60 CENTIMETERS (CM); GENDER: MALE. SAME EVENT AS MEDWATCH-NO.:3004721439-2022-00248.

  Patient problems: Hydrocephalus

  MAUDE report 15297352 ↗
• InjuryJun 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PEDIATRIC PRECHAMBER (#FV035T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. 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. AGE: 6 YEARS, HEIGHT: 89 CENTIMETERS (CM), WEIGHT: 10.5 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH-NO. 3004721439-2022-00173.

  Patient problems: Hydrocephalus

  MAUDE report 14775442 ↗
• InjuryNov 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  SAME EVENT AS MEDWATCH # 3004721439-2021-00297.

  Patient problems: Hydrocephalus

  MAUDE report 12761680 ↗
• InjuryApr 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  SAME PATIENT/EVENT: MEDWATCH#3004721439-2021-00064.3

  Patient problems: Hydrocephalus

  MAUDE report 11627494 ↗
• InjurySep 17, 2020Complete Blockage; Complete Blockage

  THE COMPLAINANT REPORTED THAT A PROGAV 2.0 WITH SHUNT ASSISTANCE 20 (PART # FX413T) (REF. ASSOCIATED MDR ID 3004721439-2020-00182) AND PRECHAMBER (PART # FV035T) WERE IMPLANTED IN A PATIENT ON (B)(6) 2019. REPORTEDLY, CONTRAST MEDIUM WAS INJECTED INTO THE DEVICE, WHICH REVEALED THAT THE FLOW WAS BLOCKED AT THE LOCATION OF THE SHUNT VALVE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. NO KNOWN PATIENT COMPLICATIONS. NO FURTHER ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH: 3004721439-2020-00182.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10546417 ↗