AESCULAP FV046TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906131395), received between Sep 14, 2020 and Oct 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (REGARDING MEDWATCH FORM (B)(4)) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. THE SPRUNG RESERVOIR SET (FV046T) FROM THIS REPORT WAS SUBSEQUENTLY CONNECTED TO THE ABOVEMENTIONED PROGAV 2.0 SHUNTSYSTEM BY THE HOSPITAL. 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 20426835 ↗
• InjurySep 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SPRUNR RESERVOIR (#FV146T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. 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: 54 YEARS. WEIGHT: 107 KGS. HEIGHT: 179 CM. GENDER: MALE. SAME EVENT AS # REPORTED HEREIN.

  Patient problems: Hydrocephalus

  MAUDE report 20245659 ↗
• InjurySep 16, 2024Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  THE DEVICE (PART OF #(B)(6) - VENTRICULAR CATHETER) WAS RETURNED TO THE MANUFACTURER FOR EXAMINATION.

  Patient problems: Hydrocephalus

  MAUDE report 20225140 ↗
• InjuryMay 28, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SPRUNG RESERVOIR-SET (# FV046T) WAS IMPLANTED DURING A REVISION PROCEDURE (MEDWATCH#3 004721439-2024-00120) PERFORMED ON (B)(6) 2024. THE SPRUNG RESERVOIR WAS IMPLANTED TOGETHER WITH # FX418T (MEDWATCH#3004721439-2024-00135). ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 MONTHS HEIGHT: 64 CM WEIGHT: 9 KG GENDER: MALE SAME INCIDENT/PATIENT AS MEDWATCH# 3004721439-2024-00135

  Patient problems: Hydrocephalus

  MAUDE report 19405675 ↗
• InjuryMar 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SPRUNG RESERVOIR (#FV046T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD A LEAK FROM THE CATHETER ON THE DISTAL SIDE OF THE RESERVOIR. THE RESERVOIR WAS EXPLANTED AGAIN. THE COMPLAINANT'S 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 18967886 ↗
• InjuryJan 27, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SPRUNG RESERVOIR (PART#: FV046T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE RESERVOIR IN COMBINATION WITH A PROGAV 2.0 WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. 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. AGE: 17 YEARS, HEIGHT: 153 CENTIMETERS (CM), WEIGHT: 57 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH#: 3004721439-2022-00435 AND 3004721439-2022-00437.

  Patient problems: Hydrocephalus

  MAUDE report 16258259 ↗
• InjuryApr 9, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A SPRUNG RESERVOIR (PART # FV046T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SPRUNG RESERVOIR MALFUNCTIONED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WILL 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#3004721439-2021-00067.

  Patient problems: Hydrocephalus

  MAUDE report 11645019 ↗
• InjurySep 14, 2020Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  THE INFORMATION THAT THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION IS REACHED TO US ON 10/06/2020. ASSOCIATED MEDWATCH # 3004721439-2020-00184.

  Patient problems: Hydrocephalus

  MAUDE report 10532295 ↗