Performa® 00884450001431Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884450001431), received between Oct 14, 2020 and Aug 27, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR REPAIR CASE IT WAS FOUND THAT THE CATHETER STRAIGHTENER WENT THROUGH THE HUB OF THE SHEATH AND WAS DEPLOYED IN THE PATIENT. THIS HAD TO BE SURGICALLY REMOVED. THIS ISSUE WAS IDENTIFIED WHEN THE PATIENT PRESENTED WITH CLAUDICATION A FEW DAYS AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Pain; Reduced Blood Flow

  MAUDE report 22910003 ↗
• InjuryMay 10, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PROCEDURE, THE RADIOPAQUE MARKER BAND ON THE 5F PIGTAIL VESSEL SIZING CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908696 ↗
• InjuryAug 24, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOPLASTY, THE TIP OF THE IMPRESS CATHETER BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP USING A FOGARTY EMBOLECTOMY CATHETER AND SNARE. NO PATIENT INJURY TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12362479 ↗
• InjuryAug 17, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE THE DOCTOR WAS PERFORMING SURGERY, A SCHEDULED FENESTRATED ENDOVASCULAR AORTIC REPAIR, ON PATIENT. AT 1331, DOCTOR STATED THAT THE TIP OF THE 5F BERN CATHETER HAD BROKEN OFF IN THE PATIENT. THE BACK PORTION OF THE CATHETER WAS REMOVED. THE BROKEN CATHETER PIECE REMAINED ON THE WIRE AND DID NOT MOVE. DOCTOR WAS ABLE TO REMOVE ALL OF THE BROKEN PIECES USING A 10MM SNARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12333501 ↗
• InjuryAug 17, 2021Fracture; Material Separation; Fracture; Material Separation

  DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, THE TIP OF THE IMPRESS CATHETER BROKE DURING A PULL BACK MANEUVER AFTER CONTRAST IMAGE (PTA). THE DISTAL END WAS BECAME STUCK DUE TO A CALCIFIED VESSEL. THE ENTIRE DEVICE WAS REMOVED BY THE PROVIDER WITH NO ASSISTIVE DEVICES. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333498 ↗
• MalfunctionAug 11, 2021Fracture; Material Separation; Fracture; Material Separation

  DURING THE AVF PROCEDURE, TIP OF THE IMPRESS CATHETER WAS FOUND DETACHED FROM THE CATHETER BODY UNDER FLUOROSCOPY, WHEN ATTEMPTING TO PUT THE CATHETER IN THE PATIENT'S VESSEL. THE TIP HAD NOT COMPLETELY SEPARATED FROM THE CATHETER AND WAS REMOVED FROM THE PATIENT OVER THE RADIOFOCUS .035 TERUMO GUIDEWIRE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE NEEDED. A NEW DEVICE WAS PREPPED AND USED TO COMPLETE THE PROCEDURE. NO PATENT INJURY TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306955 ↗
• InjuryAug 11, 2021Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTS THAT, DURING A FEMORAL ARTERY ANGIOPLASTY, THE BEACON TIP DISLODGED FROM THE IMPRESS CATHETER. THE PROCEDURE WAS STOPPED AND THE TIP WAS RETRIEVED BY SNARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306953 ↗
• InjuryAug 11, 2021Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER ALLEGES THAT A PIECE OF AN ANGIOGRAPHIC CATHETER BROKE WITH A PIECE REMAINING IN PATIENT DURING AN ANGIOGRAM. THE PROCEDURE WAS THEN CONVERTED TO A CUTDOWN APPROACH TO ATTEMPT TO RETRIEVE THIS PART OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306950 ↗
• InjuryJul 22, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE DEVICE HAD TO BE REMOVED FROM THE PATIENT AND A NEW DEVICE USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12214282 ↗
• MalfunctionOct 14, 2020Fracture; Fracture

  ACCOUNT ALLEGES THAT DURING A VENOGRAM OF ILIAC VEINS WITH 3D SPINS WITH 100 ML INJECTIONS THROUGH A PIGTAIL, THE CATHETER WAS FOUND TO BE FRACTURED UPON REMOVAL. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10680959 ↗