CentrosFLORecalls & reported problems across all models
Merit Medical Systems, Inc. · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CentrosFLO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 27 models of CentrosFLO by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2019 and Aug 6, 2025 — classified as 8 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
CentrosFLO 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-1575-2026 · Root cause: Process control · names 27 of these models · Recall details · FDA record ↗
Most reported CentrosFLO problems
Device problems
- Fracture4
- Adverse Event Without Identified Device or Use Problem3
- Difficult or Delayed Separation3
- Material Separation3
- Material Integrity Problem2
- Device-Device Incompatibility1
- Difficult to Insert1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient3
- Cardiac Tamponade1
- Hemorrhage/Blood Loss/Bleeding1
- Internal Organ Perforation1
- No Information1
- Pericarditis1
- Thrombosis/Thrombus1
CentrosFLO models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CentrosFLO® 00884450276129Catheter, hemodialysis, implanted1 recall7 reports
- CentrosFLO® 00884450200018Catheter, hemodialysis, implanted1 recall5 reports
- CentrosFLO® 00884450200025Catheter, hemodialysis, implanted1 recall3 reports
- CentrosFLO® 00884450276105Catheter, hemodialysis, implanted1 recall2 reports
- CentrosFLO® 00884450295540Catheter, hemodialysis, implanted1 recall2 reports
- CentrosFLO® 00884450199992Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450200001Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450200056Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450200063Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450276068Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450276082Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® Initial ReleaseCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® Initial ReleaseCatheter, Hemodialysis, Implanted1 recall0 reports
- CentrosFLO® ACatheter, Hemodialysis, Implanted1 recall0 reports
- CentrosFLO® 00884450295564Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450295588Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® ACatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450725917Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450725993Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450726006Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® 00884450726013Catheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
- CentrosFLO® DCatheter, hemodialysis, implanted1 recall0 reports
Recent CentrosFLO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THE PEELAWAY SHEATH WAS DIFFICULT TO TEAR MAKING IT DIFFICULT TO USE. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731605 ↗MalfunctionJul 8, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THE PEELAWAY SHEATH WAS DIFFICULT TO TEAR, MAKING IT DIFFICULT TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440607 ↗MalfunctionJul 8, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THE PEELAWAY SHEATH IS DIFFICULT TO TEAR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440604 ↗MalfunctionMay 22, 2025Difficult to Open or Close; Difficult to Open or Close
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE CLINICIAN TRIED TO PEEL AWAY THE SHEATH AND IT DID NOT PEEL AWAY PROPERLY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072763 ↗InjuryMay 6, 2025Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem
THE ACCOUNT ALLEGES THAT WHEN THE IMPLANTED CATHETER WAS FLUSHED WITH SALINE, BLOOD LEAKED FROM THE JOINT BETWEEN THE JUNCTION PART AND THE EXTENSION TUBE. THE CATHETER WAS CLAMPED WITH FORCEPS AND THE PATIENT TRANSFERRED TO THE HOSPITAL WHERE THE CATHETER REPLACEMENT PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970034 ↗MalfunctionMar 5, 2025Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem
THE ACCOUNT ALLEGES THAT POST IMPLANT OF THE DOUBLE LUMEN HEMODIALYSIS CATHETER, THE FLOW OF THE DEVICE WAS TESTED. THE FLOW WAS NOT SMOOTH AND OCCLUSION WAS SUSPECTED. THE CATHETER WAS REMOVED AND BUBBLES WERE OBSERVED. A NEW DEVICE WAS IMPLANTED IN ITS PLACE. NO ADDITIONAL DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526291 ↗InjuryJan 22, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THE CUSTOMER ALLEGES THAT THE VALVE OF THE PEEL-AWAY SHEATH WAS ATTACHED IN AN IRREGULAR SHAPE. ALTHOUGH THE PHYSICIAN USING THE DEVICE FELT DISCOMFORT WITH IT, HE USED THE PRODUCT, WHICH RESULTED IN SEVERE BLEEDING FROM THE PATIENT. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AFTER THE PROCEDURE. THE CATHETER ITSELF WAS IMPLANTED, AND THE PATIENT STARTED DIALYSIS WITHOUT ANY PROBLEMS FROM THE FOLLOWING DAY OF THE OCCURRENCE DATE. THE PATIENT HAD SEVERE VALVULAR DISEASE AS AN UNDERLYING CONDITION, WHICH MAY HAVE CAUSED THE SEVERE BLEEDING, BUT THE CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S BLEEDING AND HIS/HER UNDERLYING CONDITION IS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21209499 ↗MalfunctionJul 25, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THE VALVE WAS BROKEN AND IT WAS UNABLE TO BE USED. THE CATHETER FELL APART AND THE HEMOSTATIC VALVE RUPTURED AND THERE WAS BLOOD LEAKING. THE DEVICE HAD TO BE SWITCHED OUT FOR ANOTHER ONE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393793 ↗InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A PLACEMENT PROCEDURE OF A HEMODIALYSIS CATHETER, THE PATIENT DEVELOPED PERICARDIAL HEMATOMA AND RIGHT ATRIUM ENDOCARDIUM PERFORATION FROM THE TIP OF THE SYLET OF THE CATHETER. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Internal Organ Perforation; Pericarditis
MAUDE report 17027370 ↗InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITERATURE REVIEW FOUND AN EVENT WHERE EXPOSURE TO THE DIALYSIS CATHETER CAUSED SUBDERMAL TUNNEL, CATHETER INFECTION, THROMBOSIS FORMATION WITHIN RIGHT ATRIUM, AND FIBRIN SHEATH FORMATION. OPEN-CHEST HEART SURGERY WAS REQUIRED TO WITHDRAW THE DEVICE OUT. AFTER THE SUCCESSFUL TREATMENT, THE PATIENT RETURNED BACK TO ANOTHER HOSPITAL SHE HAD BEEN ORIGINALLY HOSPITALIZED FOR DEMENTIA.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 16383886 ↗InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES A CENTROSFLO CATHETER WAS PLACED FOR BLOOD ACCESS THROUGH THE RIGHT INTERNAL JUGULAR VEIN FOR CHRONIC KIDNEY FAILURE. THE PUNCTURE WAS DIFFICULT BUT SUCCESSFUL. BLOOD WAS CONFIRMED TO BE FLOWING FROM THE PUNCTURE NEEDLE BEFORE PROCEEDING WITH THE PROCEDURE. THE CATHETER WAS PLACED WITHIN THE PATIENT BUT BLOOD COULD NOT BE ASPIRATED FROM THE CATHETER. CONTRAST AGENT WAS INJECTED THROUGH THE CATHETER AND IT WAS DISCOVERED THE CATHETER WAS INSERTED OUTSIDE OF THE VESSEL. IT IS BELIEVED THE EVENT WAS CAUSED BY INSERTION OF THE GUIDEWIRE FROM THE PROXIMAL END. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE INSERTION OF A NON-MERIT DIALYSIS CATHETER INTO THE RIGHT GROIN. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. AT THE SECOND HOSPITAL, THE CENTROSFLO WAS WITHDRAWN AND SUCCESSFULLY REPLACED WITH A NEW UNIT THROUGH THE LEFT INTERNAL JUGULAR VEIN. A SHUNT IS PLANNED TO BE MADE ON THE RIGHT FOREARM AGAINST CKD IN THE FUTURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14239567 ↗MalfunctionOct 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO PLACE A CATHETER THIS MORNING. WHEN PLACING THE CATHETER, THE CUFF ON THE CATHETER WAS LOOSE, SO THEY OPENED ANOTHER CATHETER. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576879 ↗MalfunctionJul 20, 2021Difficult to Insert; Difficult to Insert
THE ACCOUNT ALLEGES THAT THE STYLET COULD NOT BE PASSED THROUGH THE CATHETER AND GOT STUCK AT THE HUB. THE UNIT WAS REPLACED AND SUCCESSFULLY ALLOWED FOR THE PASSING THROUGH OF A STYLET. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12200011 ↗InjuryFeb 17, 2021Material Too Rigid or Stiff
THE ACCOUNT ALLEGES THAT THE WIRE WAS TOO STIFF WHEN USING THE DEVICE TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT CONDITION WORSENED AND CARDIAC TAMPONADE OCCURRED.
Patient problems: Cardiac Tamponade
MAUDE report 11338146 ↗MalfunctionSep 24, 2020Material Deformation; Material Deformation
THE ACCOUNT ALLEGES THAT AFTER ONE-WEEK POST HEMODIALYSIS CATHETER PLACEMENT ON A BILATERAL AMPUTEE PATIENT, A CLEAR TUBE WAS FOUND TO BE PROTRUDING FROM WITHIN THE LONG TERM DIALYSIS CATHETER. THE CATHETER HAS NOT YET BEEN WITHDRAWN FROM THE PATIENT AND IS STILL CURRENTLY USED DURING DIALYSIS TREATMENT AS A TEMPORARY MEASURE. THE HOSPITAL IN-PATIENT DIALYSIS PROCEDURE IS EXTENDED DUE THE DEFORMITY OF THE CATHETER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10584504 ↗
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.
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