DiscofixRecalls & reported problems across all models
B. Braun Medical Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 74
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of Discofix by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2016 and May 15, 2026 — classified as 3 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (54 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Discofix problems
Device problems
- Leak/Splash54
- Fluid/Blood Leak5
- Break4
- Degraded4
- Detachment of Device or Device Component3
- Device Operates Differently Than Expected3
- Contamination /Decontamination Problem1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Awareness During Anesthesia7
- Low Blood Pressure/ Hypotension6
- No Consequences Or Impact To Patient5
- Blood Loss3
- Inadequate Pain Relief2
- Low Oxygen Saturation2
- No Known Impact Or Consequence To Patient2
Discofix models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Discofix® 456020ACCESSORIES, CATHETER60 reports
- Discofix® 456003ACCESSORIES, CATHETER12 reports
- Discofix® 455991ACCESSORIES, CATHETER1 report
- Discofix® 455980ACCESSORIES, CATHETER1 report
Recent Discofix adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 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 ↗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 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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