Performa® 00884450002612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450002612), received between Jul 10, 2023 and Jul 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR, THE CATHETER SEPARATED FROM THE END INTO TWO PIECES. ANOTHER CATHETER WAS USED WITHOUT DIFFICULUTIES. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347425 ↗
• MalfunctionJul 10, 2023Material Separation

  ELDERLY MALE WITH ABDOMINAL AORTIC ANEURYSM. PROCEDURE: ABDOMINAL AORTIC ANEURYSM REPAIR. THE PIGTAIL CATHETER SEPARATED FROM THE END INTO 2 PIECES. ANOTHER PIGTAIL USED WITHOUT DIFFICULTIES. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, DIAGNOSTIC, PERFORMA (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286473 ↗