DuraMaxRecalls & reported problems across all models
Merit Medical Systems, Inc. · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one 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
- 1
- Injuries reported
- 12
- Recalls
- 1
We found 21 models of 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 7, 2025 and Mar 30, 2026 — classified as 1 death, 12 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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
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, 2026Class IOpen, 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-1578-2026 · Root cause: Process control · names 21 of these models · Recall details · FDA record ↗
Most reported DuraMax problems
Device problems
- Patient Device Interaction Problem7
- Migration4
- Migration or Expulsion of Device4
- Separation Failure3
- Difficult or Delayed Separation2
- Difficult to Remove2
- Fracture2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Unspecified Infection3
- Air Embolism1
- Airway Obstruction1
- Bacterial Infection1
- Brain Injury1
- Cardiac Arrest1
- Convulsion/Seizure1
DuraMax models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DuraMax®Catheter, hemodialysis, implanted1 recall1 death9 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall9 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall1 report
- DuraMax®Catheter, hemodialysis, implanted1 recall1 report
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMax®Catheter, hemodialysis, implanted1 recall0 reports
- DuraMaxCatheter, hemodialysis, implanted1 recall0 reports
Recent DuraMax adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Break
CUSTOMER REPORTS THE SHEATH BROKE AT THE WRONG LOCATION; PHYSICIAN HAD TO RETRIEVE IT FROM WITHIN THE PATIENT. NO ADDITIONAL DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735053 ↗MalfunctionMar 24, 2026Separation Problem
THE CUSTOMER REPORTS THAT WHEN USING THE DURAMAX, THE STAFF AND PHYSICIANS WERE UNABLE TO EASILY DETACH FROM THE PEEL AWAY SHEATH. THE CATHETER WAS ALREADY IMPLANTED IN THE PATIENT AND UPON REMOVAL, THE SHEATH WOULD NOT DETACH. ALL THE OTHER COMPONENTS OF THE KIT WORKED, WITH THE THIS BEING ONE OF THE LAST STEPS IN THE PROCESS, THE TEAM JUST MADE IT WORK SO THEY DIDN'T HAVE TO REDO THE WHOLE PROCESS AGAIN ON THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680251 ↗MalfunctionMar 24, 2026Separation Failure
THE CUSTOMER REPORTS THAT THE PEEL AWAY SHEATH WOULD NOT PEEL PROPERLY RESULTING IN OPENING ADDITIONAL SUPPLIES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673896 ↗MalfunctionMar 23, 2026Separation Failure
THE CUSTOMER REPORTS THAT THE SHEATH DID NOT PEEL AND BROKE. THERE WAS NO PATIENT INJURY AND THE REST OF CATHETER WAS SUCCESSFULLY PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670106 ↗InjuryMar 12, 2026Fracture
THE ACCOUNT ALLEGES THAT DURING DEVICE REMOVAL THROUGH THE SKIN TRACT, THE METAL COMPONENT SEPARATED FROM THE PLASTIC SLEEVE AND REMAINED UNDER THE PATIENT'S SKIN. THE RETAINED COMPONENT WAS MANUALLY RETRIEVED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583611 ↗InjuryMar 12, 2026Fracture
THE ACCOUNT ALLEGES THAT DURING DEVICE REMOVAL THROUGH THE SKIN TRACT, THE METAL COMPONENT SEPARATED FROM THE PLASTIC SLEEVE AND REMAINED UNDER THE PATIENT'S SKIN. THE RETAINED COMPONENT WAS MANUALLY RETRIEVED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582981 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING THE PLACEMENT OF THE PERMANENT CATHETER, AT THE TIME OF INSERTION USING THE SELDINGER TECHNIQUE, WHEN THE GUIDE IS REMOVED, THE CATHETER IS RETURNED TOGETHER, CAUSING A HEMOTHORAX TO THE PATIENT DURING THE PROCEDURE.
Patient problems: Hemothorax
MAUDE report 24429252 ↗MalfunctionJul 22, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE ACCOUNT ALLEGES IT TOOK GREATER FORCE THAN USUAL TO BREAK OPEN THE COLLAR OF THE PEEL AWAY SHEATH AND ONCE OPEN THE SHEATH ONLY "PEELED" A SHORT DISTANCE. ULTIMATELY THE SHEATH HAD TO BE CUT, LENGTHWISE, TO COMPLETE THE PEEL AWAY MANEUVER AND BE APPROPRIATELY EXTRACTED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22571919 ↗InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 22384400 ↗InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 22384398 ↗InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER-RELATED INFECTION. THESE INFECTIONS NECESSITATED EARLY CATHETER REMOVAL. THE INCIDENCE RATE OF CRI IN THE DM GROUP WAS 1.14 EVENTS PER 1,000 CATHETER DAYS, WHICH WAS NOTABLY HIGHER THAN THE COMPARATOR GROUP'S RATE OF 0.67 EVENTS PER 1,000 CATHETER DAYS. ALL CATHETERS WERE IMPLANTED WITHOUT PROCEDURAL COMPLICATIONS. THIS REPORT IS BEING SUBMITTED AS A SERIOUS INJURY DUE TO THE NEED FOR MEDICAL INTERVENTION AND EARLY DEVICE REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 22384396 ↗InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384393 ↗InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384392 ↗InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384384 ↗InjuryJul 2, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration; Migration or Expulsion of Device; Patient Device Interaction Problem; Migration
IN A RANDOMIZED CLINICAL STUDY EVALUATING THE PERFORMANCE OF THE DURAMAX® TUNNELED HEMODIALYSIS CATHETER IDENTIFIED A CASE OF CATHETER DISLODGEMENT. ALL DEVICES WERE PLACED WITHOUT TECHNICAL DIFFICULTY OR PROCEDURAL COMPLICATIONS. HOWEVER, THE DM CATHETER GROUP EXHIBITED A DISPROPORTIONATELY HIGHER RATE OF DISLODGEMENT COMPARED TO THE COMPARATOR DEVICE GROUP, WHICH HAD ONLY ONE DISLODGEMENT, AND THAT PATIENT HAD A PRIOR DISLODGEMENT HISTORY WITH A DM CATHETER. THESE DISLODGEMENT EVENTS REQUIRED EARLY CATHETER REMOVAL. THIS REPORT IS BEING SUBMITTED AS A POTENTIAL DEVICE MALFUNCTION THAT MAY LEAD TO SERIOUS INJURY IF THE ISSUE WERE TO RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384381 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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