Discofix® 456020Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04046964996962), received between Jan 16, 2019 and May 15, 2026 — classified as 2 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (51 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THIS COMPLAINT DOCUMENTS THE CLAIMANT'S ALLEGATION OF MULTIPLE INCIDENTS OF LEAKAGE AND UNEXPECTED DISCONNECTION ASSOCIATED WITH THE DISCOFIX 4 WAY STOPCOCK WITH SPIN LOCK DURING ROUTINE HANDLING. THE DEVICE REPORTEDLY DISCONNECTS WITHOUT EXCESSIVE FORCE AND EXHIBITS LEAKAGE DURING NORMAL USE, WHICH MAY RESULT IN FLUID LEAKAGE, THERAPY INTERRUPTION, AND EXPOSURE RISKS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191647 ↗
• MalfunctionMar 12, 2026Crack; Leak/Splash

  AS REPORTED VIA MEDWATCH NUMBER MW5183295: PATIENT IS DNR/DNI AND CURRENTLY ON ARDSNET PROTOCOL, INTUBATED AND SEDATED. THE PLAN OVER THE PAST SEVERAL DAYS HAS BEEN TO WEAN SEDATION, AWAKEN THE PATIENT, AND ATTEMPT SPONTANEOUS BREATHING TRIALS TO ASSESS TOLERANCE FOR VENTILATOR WEANING. THIS AFTERNOON, THE PATIENT BECAME INCREASINGLY AGITATED, WITH HEART RATE IN THE 110S, SYSTOLIC BLOOD PRESSURE IN THE 200S, INCREASED VENTILATOR DYSSYNCHRONY, TEMPERATURE RISING TO >39°C, INCREASED CUFF LEAK ASSOCIATED WITH AGITATION, CPOT >3, AND INCREASED WORK OF BREATHING. FIO[?] WAS INCREASED TO 100%. TO IMPROVE COMFORT AND REDUCE RESPIRATORY DISTRESS, SEDATION WAS INITIATED/REINITIATED PER MD ORDER USING DEXMEDETOMIDINE AND PROPOFOL, WITH INFUSION TITRATIONS TO BE PERFORMED BY RN. DESPITE TITRATING SEDATION PER PROTOCOL BASED ON CPOT SCORES, THE PATIENT SHOWED NO IMPROVEMENT: CPOT REMAINED >3, VENTILATOR DYSSYNCHRONY PERSISTED, WORK OF BREATHING REMAINED HIGH, SBP STAYED IN THE 200S, AND HR REMAINED IN THE 100S. AFTER APPROXIMATELY 30 MINUTES OF TITRATION ATTEMPTS, THE RN NOTED THAT THE 4 WAY STOPCOCK USED TO INFUSE DEXMEDETOMIDINE AND PROPOFOL WAS CRACKED AND NOT DELIVERING ANY MEDICATION INTO

  Patient problems: Distress; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 24578223 ↗
• MalfunctionOct 27, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: STOPCOCKS ATTACHED TO PATIENT WERE LOOSE. DID NOT DISCONNECT FROM PATIENT BUT WERE REPLACED IMMEDIATELY UPON ASSESSMENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397910 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: PT MOTHER PUSHED CALL LIGHT AT 1600 TO ALERT RN THAT THE IV TUBING INFUSING INTO THE PURPLE LUMEN OF THE CVC HAD BROKEN AND DISCONNECTED FROM PT. RN IMMEDIATELY CLAMPED THE LINE AT THE PT AND PERFORMED A STERILE CAP CHANGE AND CHANGED ALL INFUSING MEDS (PRECEDEX,NS CARRIER, AND MED LINE). CVC HUM AND DRESSING INTACT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612803 ↗
• MalfunctionJul 17, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: STOPCOCK LEAKED AT THE CONNECTION TO THE IV LINE. DESCRIPTION OF THE PATIENT EVENT: CUSTOMER STATES THAT DUE TO THE INFUSION OF PROPOFOL NOT BEING ADMINISTERED BECAUSE OF THE LEAK, THE PATIENT ENDED UP HAVING A SEIZURE.

  Patient problems: Convulsion/Seizure

  MAUDE report 22529641 ↗
• MalfunctionJan 7, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: RN WAS TRYING TO DO A BUBBLE STUDY AND THE AWAY STOPCOCK BLEW APART UNDER PRESSURE. IT APPEARS THAT THE END THAT IS A LURE LOCK CAN'T GET ENOUGH TURNS ON THE HUB TO TIGHTLY SECURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091230 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION CICU: THE DOUBLE STOP CLOCK (BUILT TOGETHER BY 2 3 WAY STOP CLOCKS CONNECTED TOGETHER) ON THE L FEM PICC WAS CRACKED, LEAKING AND EXPOSED FOR AN UNDETERMINED ABOUT OF TIME. IT BECAME APPARENT THE STOP CLOCK WAS CRACKED AND LEAKING WHEN THE LIPIDS THAT WERE RUNNING IN THE PORT CLOSEST TO THE PATIENT BEGAN TO BACKFLOW PAST THE DISTAL PORT TO THE PATIENT TO THE CRACKED SITE. SOON AFTER BLOOD BEGAN TO BACKFLOW OUT OF THE LINE. THE LINE WAS DISCONNECTED FROM THE PATIENT AT THE RED LUMEN, CLEANED WELL WITH ALCOHOL AND HEPARIN LOCKED WHILE ANOTHER LINE CHANGE WAS PREPARED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280213 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION, STOPCOCK LEAKING. DETAILED INQUIRY DESCRIPTION: STOPCOCK LEAKING AT CONNECTION AND SOLUTION MELTING THE STOPCOCK WHEN USING HISTOACRYL SKIN ADHESIVE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279311 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: STOPCOCK WAS CRACKED ON CVP QUAD FUSE AND LEAKING; PATIENT WAS NOT RECEIVING (OR PARTIALLY RECEIVING) DRIP MEDS (CICU). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279283 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION STOPCOCK DISCONNECTED DETAILED INQUIRY DESCRIPTION PT. WAS SITTING IN BED/ACTIVELY PLAYING DURING CARES WHEN RETURN ALARM WENT OFF ON CRRT MACHINE - UPON CHECKING PT. LINE I FOUND BLOOD ON THE CHUX AND IMMEDIATELY NOTICED THE RETURN LINE HAD COME LOOSE FROM THE STOPCOCK SETUP WHERE THE CALCIUM INFUSION WAS Y'D INTO LINE. THE PATIENT WAS QUICKLY RE-ATTACHED, AND MINIMAL BLOOD LOSS OCCURRED (EST. ~10ML). I DOUBLE CHECKED/RETIGHTENED THE ATTACHMENTS AT THE LINE/STOPCOCK. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19279236 ↗
• MalfunctionApr 22, 2024Break; Break

  AS PER MEDWATCH NUMBER MW5152610: DATE OF THIS REPORT: 06-MAR-2024 DESCRIBE EVENT OR PROBLEM: DEVICE WAS UTILIZED BY THE PATIENT AND HAS HAD MULTIPLE ISSUES WITH BROKEN STOPCOCKS. NO SAMPLE, LOT NUMBER, AND/OR INITIAL REPORTER WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19153707 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 5: BRIEF INQUIRY DESCRIPTION: STOPCOCK BREAKING, LEAKING MULTIPLE TIMES. DETAILED INQUIRY DESCRIPTION 456020 HAS BEEN CONTINUALLY BREAKING, LEAKING AND NOT WORKING ON AT LEAST 4-5 BATCHES THIS YEAR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107757 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION: STOPCOCK BREAKING, LEAKING MULTIPLE TIMES. DETAILED INQUIRY DESCRIPTION 456020 HAS BEEN CONTINUALLY BREAKING, LEAKING AND NOT WORKING ON AT LEAST 4-5 BATCHES THIS YEAR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107752 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION: STOPCOCK BREAKING, LEAKING MULTIPLE TIMES. DETAILED INQUIRY DESCRIPTION 456020 HAS BEEN CONTINUALLY BREAKING, LEAKING AND NOT WORKING ON AT LEAST 4-5 BATCHES THIS YEAR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107751 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION: STOPCOCK BREAKING, LEAKING MULTIPLE TIMES. DETAILED INQUIRY DESCRIPTION 456020 HAS BEEN CONTINUALLY BREAKING, LEAKING AND NOT WORKING ON AT LEAST 4-5 BATCHES THIS YEAR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107750 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 4: BRIEF INQUIRY DESCRIPTION: STOPCOCK BREAKING, LEAKING MULTIPLE TIMES. DETAILED INQUIRY DESCRIPTION 456020 HAS BEEN CONTINUALLY BREAKING, LEAKING AND NOT WORKING ON AT LEAST 4-5 BATCHES THIS YEAR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107746 ↗
• InjuryMay 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: WRITER AND STAFF CAME INTO PATIENT'S ROOM TO TURN PATIENT AS IT WAS TIME FOR PATIENT TO BE TURNED. POST TURN, WRITER NOTED PATIENT TO HAVE A SUDDEN DROP IN OXYGEN SATURATIONS DESPITE SUCTIONING PATIENT'S TRACHEOSTOMY AND A DROP IN BLOOD PRESSURE WITH INCREASED COUGHING. POST TURN, WHEN WRITER WENT TO INCREASE PATIENT'S PROPOFOL INFUSION, WRITER NOTED WHITE FLUID ON PATIENT'S SHEETS AND NOTICED THAT PATIENT'S STOPCOCKS WERE LEAKING THAT CONTAINED SEDATION (PROPOFOL) AND ANALGESIC (FENTANYL). WRITER GOT RID OF ALL THE STOPCOCKS AND APPLIED NEW ONES TO PATIENT'S PICC LINE TO ENSURE ALL OF THE SEDATION/ANALGESIC WAS INFUSING. WRITER HAD TO GIVE PATIENT A PRN BOLUS TO CATCH UP ON MISSED DOSES OF THE INFUSION. PATIENT'S MEDICAL CONDITION PATIENT IN HYPERCARBIC RESPIRATORY FAILURE SECONDARY TO OBESITY, HYPOVENTILATION SYNDROME AND OBSTRUCTIVE SLEEP APNEA. PATIENT SEDATED AND INTUBATED POST-SURGERY AT TIME OF INCIDENT.

  Patient problems: Cough; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 16899086 ↗
• MalfunctionJan 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AFTER TURNING PATIENT, I ASSESSED FEMORAL LINE AND SAW THE PORT RUNNING VASOPRESSORS WAS BACKING UP WITH BLOOD AND SAW THE STOPCOCK HAD DISCONNECTED AND THE LUER WAS COMPLETELY BROKEN OFF. 2 STOP COCKS REPLACED WITH THIS PATIENT. PATIENT BECAME HYPOTENSIVE AN MEDS HAD TO BE MODIFIED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16223761 ↗
• MalfunctionDec 20, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: STOPCOCK CRACKED AND FOUND TO BE LEAKING, PATIENT STARTED TO WAKE UP AND PROPOFOL WAS LEAKING, STOPCOCK CHANGED. NO PATIENT INJURY REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 16017850 ↗
• MalfunctionNov 23, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): FLUID SPRAYING "FROM" STOPCOCK, AFFECTED PATIENT'S SEDATION. NO INJURY REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 15854398 ↗
• MalfunctionNov 21, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: NOTED MEDICATIONS WERE LEAKING ONTO PILLOW UNDER PATIENT'S ARM, PATIENT MORE AWAKE. CONNECTIONS CHECKED AND INTACT BUT LEAKING REMAINED. PATIENT MORE AWAKE, DOWN OCCLUSION COMING UP ON IV PUMPS. CHANGED ALL STOPCOCKS TO RESOLVE THE PROBLEM AS WAS UNABLE TO IDENTIFY WHICH ONE BROKEN/FAULTY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833440 ↗
• MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: NOTED LEAKAGE OF DRUGS AROUND STOPCOCK - PILLOW WET - CONNECTION CHECKED AND TIGHT - STOPCOCKS CHANGED - MEDS RUNNING WERE SEDATIVES AND PRESSORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804493 ↗
• MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CHANGING THE LINE ON THE PROPOFOL WHEN I ATTACHED IT TO THE STOPCOCK IT BEGAN TO LEAK. CONNECTIONS WERE CHECK, BACK BLOOD FLOW FROM CENTRAL LINE. PT BEGAN TO WAKE, STOPCOCKS CHANGED ON PROPOFOL, FENTANYL AND INSULIN.

  Patient problems: Awareness During Anesthesia

  MAUDE report 15804486 ↗
• MalfunctionOct 19, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: STOPCOCK FOUND TO BE LEAKING. SEDATION HAD BEEN INFUSING AND PATIENT WAS EXTREMELY AGITATED. ONCE STOPCOCK REPLACED, PATIENT WAS RECEIVING ADEQUATE DOES OF SEDATION AND WAS NOW CALM. NO INJURY REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15632719 ↗
• MalfunctionOct 19, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: STOPCOCKS (BLUE) LEAKING DESPITE TIGHTENING AND SECURING ALL STOPCOCKS. LEAKING SEDATION MEDICATIONS, ALL STOPCOCKS CHANGED BUT STILL LEAKING. OLD STOPCOCKS (YELLOW) IN STOCK ON UNIT SO BLUE STOPCOCKS ALL THROWN AWAY FROM PATIENT AND CHANGED TO YELLOW STOPCOCKS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632699 ↗