Performa® 00884450005804Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450005804), received between Nov 16, 2021 and Oct 1, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 1, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT THEY USED THE CATHETER TO PASS A NARROW LESION IN THE ILIAC VESSEL. WHEN THE DOCTOR BACKED THE CATHETER OVER THE GUIDE WIRE WITH SOME FRICTION THE WHITE TIP LOOSENED AND WAS LEFT IN THE PATIENT OVER THE GUIDE WIRE. THE TIP OF THE CATHETER DETACHED AT THE WELD. THE DOCTOR MANAGED TO REMOVE THE TIP WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345442 ↗
• InjuryNov 16, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, UNDER FLUOROSCOPY THE TIP DETACHED. THE PHYSICIAN SUCCESSFULLY USED A VASCULAR SNARE DEVICE TO EXTERNALIZED THE FOREIGN BODY LIBERATING THE VESSEL WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823477 ↗