CentrosFLO® 00884450200018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450200018), received between Oct 10, 2019 and Aug 6, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. 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-1575-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗
• InjuryNov 25, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PERIPHERAL INTERVENTION, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED IPSILATERAL RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDE-WIRE AND 4F CATHETER. DURING CATHETER WITHDRAW FROM THE SHEATH IS WAS NOTED THAT THE CATHETER TIP HAD DETACHED YET REMAINED ON THE GUIDE-WIRE WITHIN THE PATIENT'S AORTIC BIFURCATION. THE PHYSICIAN UP-SIZED THE SHEATH TO 7F AND NOTED SOME CALCIFICATION IN THE PATIENT'S VASCULATURE THAT MAY HAVE CONTRIBUTED TO THE TIP DETACHMENT DURING CATHETER REMOVAL. THE GUIDE WIRE AND THE CATHETER TIP WERE BOTH SUCCESSFULLY REMOVED WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371266 ↗
• InjuryNov 25, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANS JUGULAR LIVER BIOPSY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S HEPATIC VEIN. THE PHYSICIAN ACQUIRED ANTEGRADE VENOUS ACCESS AND DURING CATHETER MANIPULATIONS THE TIP DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE CATHETER TIP WITH A VASCULAR SNARE DEVICE WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371227 ↗
• MalfunctionOct 10, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE THE CATHETER TIP BROKE INTO SMALL PIECES. NO ADDITIONAL PROCEDURES/INTERVENTIONS WERE NEEDED FOR THIS PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Information

  MAUDE report 9176889 ↗