Performa® 00884450766552Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Performa (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450766552), received between Apr 1, 2025 and Sep 28, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Material Separation3
- Break2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923205 ↗MalfunctionMay 21, 2025Break; Fracture; Break; Fracture
THE ACCOUNT ALLEGES THE CATHETER DISCONNECTED FROM THE HUB WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061190 ↗InjuryApr 2, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PEDIATRIC PROCEDURE, THE DEVICE WAS FOUND TO BE LEAKING FLUID BETWEEN THE HUB AND THE CATHETER CONNECTION, OUTSIDE THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752713 ↗InjuryApr 2, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PEDIATRIC PROCEDURE, THE DEVICE WAS FOUND TO BE LEAKING FLUID BETWEEN THE HUB AND THE CATHETER CONNECTION, OUTSIDE THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752712 ↗InjuryApr 1, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PEDIATRIC PROCEDURE, THE DEVICE WAS FOUND TO BE LEAKING FLUID BETWEEN THE HUB AND THE CATHETER CONNECTION, OUTSIDE THE PATIENT'S BODY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748829 ↗
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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
- 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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