Performa® 00884450000984Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450000984), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 injury.

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.

• InjuryMar 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR LOWER ABDOMINAL RUN-OFF/CROSSOVER ANGIOPLASTY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S RIGHT LOWER LEG. THE PHYSICIAN HAD ACQUIRED LEFT RETROGRADE FEMORAL ARTERY ACCESS WITH A 6F SHEATH AND HAD NEGOTIATED THE PATIENT'S RIGHT ILIO-FEMORAL CONDUIT VIA CROSSOVER TECHNIQUE WITH A GUIDEWIRE AND A 5F PERFORMA IM CATHETER. DURING CATHETER MANIPULATIONS OTW, UNDER FLUOROSCOPY WITHIN THE PATIENT'S RIGHT PERIPHERAL VASCULAR SYSTEM, THE CATHETER TIP DETACHED. THE PHYSICIAN RETRIEVED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE SUCCESSFULLY EXTERNALIZING THE FOREIGN BODY AND LIBERATING THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587528 ↗