Performa® 00884450002506Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Performa (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450002506), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Obstruction of Flow1
Patient problems
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2024Fluid/Blood Leak; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT REPORTS DURING AN ATRIAL FIBRILLATION ABLATION, A VASCULAR DISSECTION OCCURRED WHICH RESULTED IN A PERICARDIAL EFFUSION. THE ABLATION CATHETER AND SHEATH WERE PLACED AT THE CORONARY SINUS. WHEN INJECTING THE CONTRAST AGENT INTO THE CORONARY SINUS USING THE 5F VERTEBRAL DIAGNOSTIC CATHETER, AN OBSTRUCTION WAS NOTED. WHEN REMOVING THE SHEATH FROM THE CORONARY SINUS, A DISSECTION IN THE CORONARY SINUS WAS OBSERVED. THE PATIENT WAS OBSERVED AND REMAINED HEMODYNAMICALLY STABLE. NO INTERVENTION WAS REQUIRED. ULTRASOUND WAS COMPLETED WHICH DIAGNOSED THE EFFUSION. THE EFFUSION RESOLVED ON ITS OWN WITHOUT MEDICAL OR SURGICAL TREATMENT AND THE PATIENT IS STABLE.
Patient problems: Pericardial Effusion
MAUDE report 20258467 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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