CentrosFLO® 00884450295540Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of CentrosFLO (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450295540), received between Aug 13, 2020 and Jul 25, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- 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
Device problems
- Device-Device Incompatibility1
- Fracture1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionAug 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
PHYSICIAN ALLEGES THAT DURING A PERMANENT DIALYSIS CATHETER PREPARATION, THE RED STIFFENING STYLET COULD NOT PASS THROUGH THE DIALYSIS CATHETER LUMEN. ANOTHER CATHETER WAS USED FOR THIS PROCEDURE. NO PATIENT INJURY TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10401776 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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