miniNAV® FV660TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04041906133085), received between Mar 18, 2021 and Nov 24, 2025 — classified as 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  IT WAS REPORTED THAT A MINNAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE WAS REVISED, DUE TO A FLOW BACK. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS NOW SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 23631288 ↗
• InjuryNov 17, 2025Reflux within Device; Reflux within Device

  ACCORDING TO THE COMPLAINANT A MININAV VALVE 10 "PART#: FV660T" WAS IMPLANTED ON AN UNSPECIFIED DATE. REPORTEDLY THE VALVE WAS TAKEN OUT OF THE PATIENT BECAUSE "THE ARROW WAS POINTED DISTALLY."

  Patient problems: Failure of Implant

  MAUDE report 23573193 ↗
• InjuryFeb 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO AESCULAP INC. THAT A MININAV VALVE 10 (PART# FV660T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THERE WAS A SHUNT MALFUNCTION RESULTING IN A SHUNT REVISION. UPON TESTING OF THE MINI NAV (FLUSH WITH NACL) THE FLUID DID NOT PASS THROUGH MINI NAV. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 21397811 ↗
• InjuryFeb 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A MINIVAV VALVE 10 (#FV660T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE / BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21373906 ↗
• InjuryOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A MININAV (#FV660T) 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: 10 MONTHS. HEIGHT: 50 CM. WEIGHT: 6 KG. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20424032 ↗
• InjuryOct 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A MININAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2024. 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: 9 MONTHS, HEIGHT: 65 CM, WEIGHT: 7 KG, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20422262 ↗
• InjuryAug 9, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MININAV (#FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 8 MONTHS, WEIGHT: 5.5 KILOGRAMS (KG), HEIGHT: 63 CENTIMETERS (CM), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 17494366 ↗
• InjuryOct 5, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MININAV(PART # FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN COMBINATION WITH A PROGAV 2.0 AND A M.BLUE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. 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: 6 YEARS, HEIGHT: 136 CENTIMETERS (CM), WEIGHT: 38 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH # 3004721439-2022-00303.

  Patient problems: Hydrocephalus

  MAUDE report 15547103 ↗
• InjuryOct 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MININAV (PART # FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE REASON THE REVISION WAS PERFORMED WAS NOT PROVIDED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEAR, HEIGHT: 75 CENTIMETERS (CM), WEIGHT: 10 KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15525462 ↗
• InjuryMay 21, 2021Infusion or Flow Problem; Infusion or Flow Problem

  INVESTIGATION IS COMPLETED.

  Patient problems: Hydrocephalus

  MAUDE report 11864109 ↗
• InjuryMar 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A MININAV VALVE 10 (PART # FV660T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SURGEON SUSPECTED A SLOWER OUTFLOW. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021, AND THE VALVE WAS REPLACED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. PATIENT INFORMATIONS: AGE: (B)(6), WEIGHT: (B)(6), HEIGHT: 50 CM, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11517486 ↗