BioFlo DuraMaxRecalls & reported problems across all models
Merit Medical Systems, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BioFlo DuraMax model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 19 models of BioFlo DuraMax by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2025 and Apr 23, 2026 — classified as 4 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
BioFlo DuraMax 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.
- Feb 13, 2026Open, Classified
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Z-1579-2026 · Root cause: Process control · names 18 of these models · Recall details · FDA record ↗
Most reported BioFlo DuraMax problems
Device problems
- Fluid/Blood Leak5
- Crack4
- Defective Device4
- Product Quality Problem3
- Separation Problem3
- Activation, Positioning or Separation Problem2
- Material Puncture/Hole2
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Failure of Implant2
- Air Embolism1
BioFlo DuraMax models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall10 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall4 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall3 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall1 report
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- BioFlo DuraMax®Catheter, hemodialysis, implanted2 reports
Recent BioFlo DuraMax adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967924 ↗MalfunctionApr 23, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967919 ↗MalfunctionApr 23, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967911 ↗MalfunctionApr 23, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER LEAKS AT THE BLUE PORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967900 ↗InjuryMar 26, 2026Patient Device Interaction Problem
THE CUSTOMER REPORTED THAT DURING DIALYSIS, AIR WAS ASPIRATED THROUGH THE DIALYSIS CATHETER. A DEFECTIVE DIALYSIS CATHETER WAS SUSPECTED WITH REPLACEMENT PLANNED AND TO PRESERVE THE EXPLANTED CATHETER FOR EXAMINATION PURPOSES. THE PATIENT HAD NO SYMPTOMS AT ANY TIME.
Patient problems: Failure of Implant
MAUDE report 24698212 ↗MalfunctionMar 25, 2026Missing Information
THE CUSTOMER REPORTED THAT ONE KIT OF BIOFLOW DURAMAX WAS FOUND WITHOUT A LABEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688413 ↗MalfunctionMar 25, 2026Separation Problem
THE CUSTOMER REPORTS THAT THE PEELABLE INTRODUCER OF THE DURAMAX BIOFLO DOES NOT PEEL EVENLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688214 ↗InjuryMar 25, 2026Fracture
A SEARCH IN THE ADVERSE EVENT NOTIFICATIONS (DAEN) DATABASE, REPORT NUMBER (B)(4), REPORTED THAT "A CRACK WAS NOTICED ON ONE OF THE LUMENS OF THE CATHETER AS IT LEAKED DURING FLUSHING AND AIR ASPIRATED WHEN THE CLAMPS WERE ON." NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Air Embolism
MAUDE report 24688208 ↗MalfunctionMar 20, 2026Material Integrity Problem
THE CUSTOMER REPORTED THAT THE PRODUCT WAS OPEN ONTO A STERILE TROLLEY. THE SCRUB NURSE FLUSHED THE CATHETER AND NOTICED THAT THE TIP WAS MISFORMED. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654312 ↗MalfunctionMar 12, 2026Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING DIALYSIS TREATMENT WITH A BIOFLO DURAMAX 15.5F 32 CM DUAL-VALVE SHEATH CATHETER KIT, LEAKAGE WAS OBSERVED NEAR THE LUER NECK. BLOOD LEAKAGE OCCURRED FROM THE ARTERIAL LIMB, RESULTING IN TERMINATION OF THE DIALYSIS TREATMENT. THE CATHETER WAS EXCHANGED WITH ANOTHER DEVICE. DEVICE EVALUATION CONFIRMED A FRACTURE/HOLE IN THE EXTENSION TUBING ADJACENT TO THE ARTERIAL HUB LUER. INVESTIGATION DETERMINED THE MOST LIKELY CAUSE TO BE OVER-TORQUING OF THE EXTENSION TUBING-TO-LUER HUB JUNCTION DURING CLEANING OR HANDLING. NO MANUFACTURING OR ASSEMBLY DEVIATIONS WERE IDENTIFIED IN THE DEVICE HISTORY RECORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582983 ↗MalfunctionSep 18, 2025Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THE VALVED BREAKAWAY INTRODUCER FAILED TO SPLIT UPON ATTEMPTING TO REMOVE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085437 ↗InjuryJul 29, 2025Break; Defective Device; Infusion or Flow Problem; Material Deformation; Break; Defective Device; Infusion or Flow Problem; Material Deformation
THE ACCOUNT ALLEGES A PATIENT CAME INTO THE EMERGENCY ROOM BECAUSE A CLAMP ON THE DIALYSIS CATHETER HAD BROKEN. A TEMPORARY CLAMP WAS PLACED IN BY THE EMERGENCY ROOM. THE PATIENT WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY TO HAVE THE BROKEN CLAMP REPLACED. THE CATHETER WAS SUCCESSFULLY REPAIRED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22650589 ↗MalfunctionJul 9, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO DURAMAX 15.5F 32CM DUAL VALVE SHEATH BASIC KIT. IT WAS REPORTED THAT THE BIOFLO DURAMAX CATHETER WAS LEAKING UNDER THE LUER NECK. DUE TO THE LEAK IN THE DIALYSIS CATHETER, BLOOD LEAKED FROM THE ARTERIAL LIMB; THE TREATMENT WAS ABORTED. THE CATHETER WAS EXCHANGED FOR ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461872 ↗MalfunctionJun 20, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem
THE ACCOUNT ALLEGES THAT WHEN INSERTING THE PERMCATH DURING AN OPERATION, THE PEEL AWAY SHEATH COULD NOT BE REMOVED PROPERLY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302775 ↗MalfunctionJun 18, 2025Separation Failure; Separation Failure
THE ACCOUNT ALLEGES THAT THE PEEL AWAY WING SNAPPED OFF WHILE TRYING TO PEEL THE CATHETER AWAY. THE PEEL AWAY WAS REMOVED WITH HEMOSTATS. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286385 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 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.
How reports and recalls are matched · Editorial policy · Report an error on this page