Performa® 00884450002605Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450002605), received between Aug 2, 2021 and Apr 29, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  THE ACCOUNT ALLEGES THAT CONTRAST WAS BEING INJECTED USING A POWER INJECTOR, THROUGH THE PIGTAIL CATHETER, THE CATHETER DETACHED AND SPRAYED CONTRAST FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927413 ↗
• InjuryMay 30, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING TEVAR PROCEDURE, THE CATHETER BROKE. NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027359 ↗
• InjuryAug 24, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A HEART CATHETERIZATION WITH ANGIOPLASTY ON A PEDIATRIC PATIENT, THE CATHETER CRACKED WHILE INSIDE THE PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283159 ↗
• MalfunctionAug 18, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING AN AORTIC ANEURYSM REPAIR PROCEDURE, THE CATHETER DETACHED WITHIN THE PATIENT. THE CATHETER DETACHED AT TWO LOCATIONS OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE BOTH PIECES OF THE CATHETER FORM THE PATIENT BY HAND. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338990 ↗
• MalfunctionAug 2, 2021Break

  PATIENT WITH ENLARGED AORTIC ANEURYSM WAS ADMITTED FOR AN ENDOVASCULAR REPAIR. WHEN INJECTING CONTRAST THROUGH THE CATHETER, FROM THE PERFORMA® ANGIOGRAPHIC CATHETER BROKE APART INTO 2 PIECES. BOTH PIECES WERE REMOVED WITHOUT KNOWN HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12258442 ↗