Performa® 00884450043257Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450043257), received between Nov 17, 2019 and Nov 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND WAS TRYING TO NEGOTIATE THE PATIENT'S COMMON ILIAC BIFURCATION WHEN THE CATHETER TIP DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED CATHETER TIP ALONG WITH THE GUIDEWIRE BY HAND THROUGH THE ACCESS SHEATH. THE PATIENT TOLERATED THE PROCEDURE WELL. NO PATIENT INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9333519 ↗