Performa® 00884450003282Recalls & 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
- 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 00884450003282), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES A JL 3.5 MAY HAVE BEEN POTENTIALLY RESPONSIBLE FOR A LEFT MAIN DISSECTION. THE PROCEDURE WAS A RIGHT AND LEFT HEART CATH THAT EVOLVED INTO A VESSEL DISSECTION. WHEN DEPLOYING A STENT, THE PATIENT'S RHYTHM CHANGED TO V-FIB, AND THE PATIENT ARRESTED REQUIRING THE PLACEMENT OF A VENTRICULAR ASSIST DEVICE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT POST-PROCEDURE. THE ACCOUNT ALLEGES THAT THE CATHETERS ARE TOO STIFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16191041 ↗
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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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