AESCULAP FV173TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906108304), received between Aug 11, 2021 and Oct 5, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT A DSV WITH A PRECHAMBER(PART # FV173T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2006. ACCORDING TO THE COMPLAINANT, THE CATHETER BETWEEN THE PRECHAMBER AND THE RESERVOIR WAS DISCONNECTED/RUPTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. 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: 175 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12580133 ↗
• InjurySep 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED MIETHKE THAT A DSV SYSTEM W/PRECHAMBER 10/40 (PART # FV173T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE DSV SYSTEM W/PRECHAMBER 10/40 WAS RETURNED IN DRY CONDITION IN A PLASTIC BAG. NO FURTHER INFORMATION WAS PROVIDED AS TO A SPECIFIC FAILURE. 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.

  Patient problems: Hydrocephalus

  MAUDE report 12475848 ↗
• InjuryAug 11, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A DSV SYSTEM W/PRECHAMBER 10/40DSV (PART # FV173T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE AND HAD A PROBLEM WITH ADJUSTABILITY. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. 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) YEARS, HEIGHT: 193 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12306441 ↗