CentrosFLO® 00884450200025Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 13, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450200025), received between May 22, 2025 and Jul 8, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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
Device problems
- Difficult or Delayed Separation2
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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