Discofix® 456003Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046964183577), received between Nov 29, 2016 and Feb 20, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: NICU WAS RUNNING TPN THROUGH THE STOPCOCK. THE NURSE NOTED THERE WAS VISIBLE LEAKING WHEN SHE HOOKED UP THE TPN'S. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405355 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY THE STOPCOCK LEAKED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526819 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY THE STOPCOCK LEAKED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491203 ↗
• MalfunctionJan 29, 2025Degraded; Degraded

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "WE HAVE A GROUP OF THESE 3 WAY STOPCOCKS RECEIVED THAT ARE DEFECTIVE. IF YOU LOOK CLOSELY THERE IS A DEFECT ON THE TIP THAT ATTACHES TO THE PATIENTS IV LINE. THIS IS THE FIRST BATCH WE HAVE SEEN THAT ARE DEFECTIVE." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263969 ↗
• MalfunctionFeb 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AT THE END OF THE MANUFACTURING PROCESS A PARTICULATE WAS OBSERVED IN THE FINAL PRODUCT BAG. SINCE THE DEFECT WAS NOT OBSERVED UNTIL THE END OF THE MANUFACTURING PROCESS, ALL COMPONENTS USED ARE BEING INVESTIGATED.

  Patient problems: No Patient Involvement

  MAUDE report 8379133 ↗
• MalfunctionNov 20, 2017Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: STOPCOCK-DAMAGED-BROKEN. RESULTED IN SIGNIFICANT BLOOD LOSS, AND THE PATIENT HAD TO RECEIVE A TRANSFUSION.

  Patient problems: Blood Loss

  MAUDE report 7044732 ↗
• InjuryNov 20, 2017Break; Break

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: STOPCOCK-DAMAGED-BROKEN. RESULTED IN SIGNIFICANT BLOOD LOSS, AND THE PATIENT HAD TO RECEIVE A TRANSFUSION.

  Patient problems: Blood Loss

  MAUDE report 7044725 ↗
• MalfunctionAug 29, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: LEAKAGE OF CHEMOTHERAPY DURING CHEMO EMBOLIZATION. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6828343 ↗
• MalfunctionAug 29, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: THE STOPCOCK LEAKED BLOOD DURING USE. WHILE RETURNING BLOOD TO PATIENT THROUGH A CLOSED SYSTEM, APPROXIMATELY 2-3 CC OF BLOOD LEAKED OUT OF THE DISTAL STOPCOCK CONNECTION ONTO THE PATIENT AND THE PATIENT'S MOTHER. THE PATIENT'S CLOSED SYSTEM WAS THEN FLUSHED WITH 10 CC OF NORMAL SALINE AND 300 UNITS OF HEPARIN TO THE PATIENT'S PORT AND THEN THE PATIENT WAS DE-ACCESSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6828341 ↗
• MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS THAT THE PRODUCT HAS BEEN BREAKING. FOR EXAMPLE, WHEN USING THEM TO INFLATE A BALLOON DURING AN ANGIOPLASTY, THE BLUE SWITCH WILL POP OUT OF THE STOPCOCK, AND CONTRAST WILL SPEW EVERYWHERE. THIS HAS HAPPENED AT LEAST 3 DIFFERENT TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6133856 ↗
• MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS THAT THE PRODUCT HAS BEEN BREAKING. FOR EXAMPLE, WHEN USING THEM TO INFLATE A BALLOON DURING AN ANGIOPLASTY, THE BLUE SWITCH WILL POP OUT OF THE STOPCOCK, AND CONTRAST WILL SPEW EVERYWHERE. THIS HAS HAPPENED AT LEAST 3 DIFFERENT TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6133841 ↗
• MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS THAT THE PRODUCT HAS BEEN BREAKING. FOR EXAMPLE, WHEN USING THEM TO INFLATE A BALLOON DURING AN ANGIOPLASTY, THE BLUE SWITCH WILL POP OUT OF THE STOPCOCK, AND CONTRAST WILL SPEW EVERYWHERE. THIS HAS HAPPENED AT LEAST 3 DIFFERENT TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6133824 ↗