Impress® 00884450023877Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450023877), received between Oct 5, 2021 and Nov 9, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE THE CATHETER TIP DETACHED WITHIN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764880 ↗
• InjuryApr 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE WITHIN THE CATHLAB, THE CATHETER TIP DETACHED WITH THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS UNDER FLUOROSCOPY WITH THE 6F CATHETER TO SUCCESSFULLY ACQUIRE A LEFT VENTRICULAR ANGIOGRAM [LVA] OF THE HEART. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN EFFECTIVELY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE. A NEW CATHETER WAS PREPPED AND INTRODUCED TO COMPLETE THE PROCEDURE FOR THIS PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14092434 ↗
• InjuryMar 30, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE WITHIN THE CATHLAB, THE CATHETER TIP DETACHED WITH THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS UNDER FLUOROSCOPY WITH THE 6F CATHETER TO SUCCESSFULLY ACQUIRE A LEFT VENTRICULAR ANGIOGRAM [LVA] OF THE HEART. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN EFFECTIVELY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE. A NEW CATHETER WAS PREPPED AND INTRODUCED TO COMPLETE THE PROCEDURE FOR THIS PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957725 ↗
• InjuryOct 5, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. A SNARE HAD TO BE USED TO RETRIEVE THE TIP WITHIN THE VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12576874 ↗