CentrosFLO® 00884450276129Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450276129), received between Sep 24, 2020 and Jan 22, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗