Extension SetRecalls & reported problems across all models
B. Braun Medical Inc. · 41 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
16 open recalls name at least one Extension Set model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 16
We found 41 models of Extension Set by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Jun 5, 2026 — classified as 3 injuries, 98 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (42 reports).
16 FDA recall records name at least one of these models by its device identifier, 16 still open.
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
Extension Set recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 4, 2026Class IIOpen, Classified
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Z-3089-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0639-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0637-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0636-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0635-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0634-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0633-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0632-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0631-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0630-2026 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0629-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0628-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0627-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jul 9, 2025Class IOpen, Classified
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
Z-2176-2025 · Root cause: Process control · Recall details · FDA record ↗
- Aug 8, 2024Class IIOpen, Classified
Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
Z-3144-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Sep 15, 2022Class IIOpen, Classified
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
Z-0091-2023 · Root cause: Process design · Recall details · FDA record ↗
Most reported Extension Set problems
Device problems
- Fluid/Blood Leak42
- Leak/Splash26
- Device Operates Differently Than Expected9
- Contamination /Decontamination Problem8
- Loose or Intermittent Connection6
- Free or Unrestricted Flow4
- Infusion or Flow Problem4
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient22
- No Known Impact Or Consequence To Patient12
- Blood Loss11
- Hemorrhage/Blood Loss/Bleeding5
- Chemical Exposure2
- Cardiac Arrest1
- Hemodynamic instability1
Extension Set models
41 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Extension Set 456522Set, administration, intravascular1 recall2 reports
- Extension Set 490238Set, administration, intravascular1 recall1 report
- Extension Set 490577Set, administration, intravascular1 recall0 reports
- Extension Set 490629Stopcock, i.V. Set1 recall0 reports
- Extension Set 456025ACCESSORIES, CATHETER1 recall0 reports
- Extension Set 472036Set, administration, intravascular1 recall0 reports
- Extension Set V5405Set, administration, intravascular1 recall0 reports
- Extension Set V6215Set, administration, intravascular1 recall0 reports
- Extension Set 456520Set, administration, intravascular1 recall0 reports
- Extension Set 456521Stopcock, i.V. Set1 recall0 reports
- Extension Set 473309Set, administration, intravascular1 recall0 reports
- Extension Set 474912Set, administration, intravascular1 recall0 reports
- Extension Set 490202Stopcock, i.V. Set1 recall0 reports
- Extension Set 470169Set, administration, intravascular1 recall0 reports
- Extension Set 490358Stopcock, i.V. Set1 recall0 reports
- Extension Set 490234Set, administration, intravascular1 recall0 reports
- Extension Set 490291Set, administration, intravascular1 recall0 reports
- Extension Set 490448Set, administration, intravascular1 recall0 reports
- Extension Set 490465Set, administration, intravascular1 recall0 reports
- Extension Set 490486Set, administration, intravascular1 recall0 reports
- Extension Set 471954Set, administration, intravascular20 reports
- Extension Set 470172Set, administration, intravascular13 reports
- Extension Set 470073Set, administration, intravascular11 reports
- Extension Set 470195Set, administration, intravascular10 reports
- Extension Set 471959Set, administration, intravascular7 reports
- Extension Set 473041Set, administration, intravascular5 reports
- Extension Set 470058Set, administration, intravascular5 reports
- Extension Set 471960Set, administration, intravascular4 reports
- Extension Set V6222Set, administration, intravascular4 reports
- Extension Set V6223Set, administration, intravascular4 reports
- Extension Set 490443Set, administration, intravascular4 reports
- Extension Set 471950Set, administration, intravascular2 reports
- Extension Set 456030Set, administration, intravascular1 report
- Extension Set 471957Set, administration, intravascular1 report
- Extension Set 490540Set, administration, intravascular1 report
- Extension Set 471973Set, administration, intravascular1 report
- Extension Set V5484Set, administration, intravascular1 report
- Extension Set 470065Set, administration, intravascular1 report
- Extension Set 490203Set, administration, intravascular1 report
- Extension Set 470166Set, administration, intravascular1 report
- Extension Set 490445Set, administration, intravascular1 report
Recent Extension Set adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: BLOOD BACKING UP INTO THE LINES AND IT IS LEAKING FROM PORTS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25406769 ↗MalfunctionFeb 23, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: AIR IS ENTERING THE LINE AT THE STOPCOCK. NO INJURY REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414864 ↗MalfunctionFeb 17, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: END USER REPORTS A LEAKING FILTER EXTENSION SET (REF 470073). IT WAS LEAKING CHEMO IN BETWEEN THE LUER CONNECTOR AND TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372960 ↗MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: RN ABOUT TO CHECK FOR BLOOD RETURN (FOR CHEMO INFUSION) FROM LOWER PORT WHERE SYRINGE LINE SCREWS IN. NOTED THAT THE INNER TUBING HAD CRACKED. OTHER RN DESCRIBED THE INNER TUBING AS "EATING INTO THE RUBBER OF THE PORT". PLEASE NOTE BLOOD IN THE LINE OCCURRED WHEN IV FLUIDS WERE STOPPED - NO PRESSURE FROM IV FLUID CAUSED BLOOD TO BACKFLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714986 ↗MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION, BACKFLOW OF BLOOD & MEDICATION INTO TUBING AND SYRINGE. DETAILED INQUIRY DESCRIPTION TWO INSTANCES OF LEAKAGE AND BACKFLOW INTO BD SYRINGE DURING INFUSION. SETUP INVOLVES A PERFUSOR, B. BRAUN TUBING (V6223), BD 10ML SYRINGE & HEMODIALYSIS MACHINE. LEAKAGE OCCURRED AT B. BRAUN TUBING CONNECTION TO BD 10ML LUER LOCK. FIRST INCIDENT INVOLVED IRON SUCROSE INFUSION, SECOND INCIDENT INVOLVED FERROC GLUCONATE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713455 ↗MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION BACKFLOW OF BLOOD & MEDICATION INTO TUBING AND SYRINGE. DETAILED INQUIRY DESCRIPTION TWO INSTANCES OF LEAKAGE AND BACKFLOW INTO BD SYRINGE DURING INFUSION. SETUP INVOLVES A PERFUSOR, B. BRAUN TUBING (V6223), BD 10ML SYRINGE & HEMODIALYSIS MACHINE. LEAKAGE OCCURRED AT B. BRAUN TUBING CONNECTION TO BD 10ML LUER LOCK. FIRST INCIDENT INVOLVED IRON SUCROSE INFUSION, SECOND INCIDENT INVOLVED FERROC GLUCONATE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713454 ↗InjuryJun 27, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: CHICKEN FOOT EXTENSION SET WITH VASOACTIVE MEDS RUNNING THROUGH IT, CRACKED, IN WHICH PATIENT'S HEMODYNAMICS BECAME UNSTABLE WHICH LED TO POST-OPERATIVE BLEEDING AND REQUIRED RETURN TO OR.
Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22345418 ↗MalfunctionJun 27, 2025Crack; Leak/Splash; Reflux within Device; Crack; Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: DESCRIPTION: BEDSIDE RN DISCOVERED CRACK IN GREEN HUB OF BRAUN SMALLBORE TRIPLE-LEG EXTENSION SET. THIS EXTENSION SET WAS ATTACHED TO PATIENTS L FEM TRIPLE LUMEN CVC. AS A RESULT, BLOOD BACK FLOWED IN LUMEN AND THROUGH CRACK- PATIENT WAS NOT RECEIVING THE PRESSORS INFUSING THROUGH LINE AND SIMULTANEOUSLY BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22345244 ↗MalfunctionMar 24, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING EXT SET. DETAILED INQUIRY DESCRIPTION: WHEN FLUSHED OR INFUSING, LEAKS WHERE CONNECTED TO T-CONNECTOR. UPON GIVING BEDSIDE REPORT ON (B)(6) 2025 AT 07:30 IT WAS NOTED THAT THERE WAS A SMALL DAMP SPOT ON PATIENT BLANKET. A SMALL AMOUNT OF BLOOD WAS NOTED IN THE T-CONNECTOR. BLANKET WAS NOT STICKY, BUT DECISION MADE BY NIGHT AND DAY SHIFT NURSE TO FLUSH IV. PATIENT DID NOT APPEAR TO HAVE ANY OTHER SOURCE FOR WETNESS AT THE TIME (WRONG LOCATION FOR DROOL OR EMESIS OR OG TUBE ASPIRATE). UPON FLUSHING IV, FLUID SPURTED OUT OF A TINY CRACK IN THE GREEN HUB COLORED T-CONNECTOR. IV WAS TAKEN DOWN TO THE YELLOW HUB. ASEPTIC TECHNIQUE USED. NEW T-CONNECTOR ATTACHED. IV SECURED WITH NEW TEGADERM AND TAPE. PIV FLUSHED WITHOUT DIFFICULTY. PIV INFUSION OF D10% CONTINUED WITHOUT DELAY. IMMEDIATELY PLACED FAULTY T-CONNECTOR IN TO A BAG WITH FLUSH ATTACHED. PIV HAD BEEN PLACED THE DAY BEFORE AND PACKAGING FOR T-CONNECTOR WAS UNABLE TO BE LOCATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21678997 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2, BRIEF INQUIRY DESCRIPTION: OPEN INFUSION PORTS/SPOTS ON INJECTION PORT. DETAILED INQUIRY DESCRIPTION: 18 TWISTS OFF PORTS (INFUSION PORTS OPEN AT SEAL), 2 VISUALS (BLACK/BROWN SPECKS ON INJECTION PORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631025 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION OPEN INFUSION PORTS/SPOTS ON INJECTION PORT DETAILED INQUIRY DESCRIPTION 18 TWIST OFF PORTS(INFUSION PORTS OPEN AT SEAL) 2 VISUALS (BLACK/BROWN SPECKS ON INJECTION PORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631021 ↗MalfunctionJan 30, 2025Leak/Splash; Leak/Splash
PER UF/IMPORTER REPORT # (B)(4): DESCRIBE THE EVENT OR PROBLEM: MICROBORE EXTENSION SET LEAKING AT GREEN HUB WHILE INFUSING DOPAMINE. PATIENT EXPERIENCED DECREASED ARTERIAL PRESSURE. PATIENT REQUIRED NORMAL SALINE BOLUS, INCREASED DOPAMINE AND INCREASED EPINEPHRINE FOLLOWING THIS ISSUE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MEDICATION INFUSION WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: CARDIAC DRUGS. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: NONE OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: HYPERTENSION.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 21272905 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 1: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350825 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 1: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350794 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 3: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350772 ↗
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
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
- Caresite23 models · 420 reports · 4 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page