Skip to content

Impress® 00884450035849Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

All models of Impress (145)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450035849), received between Jan 3, 2024 and Jan 3, 2024 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture2
  • Material Separation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 3, 2024Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE RADIAL ARTERY WAS USED FOR VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS, THE PIGTAIL CATHETER TIP DETACHED WITHIN THE PATIENT'S SUBCLAVIAN ARTERY. A VASCULAR SNARE DEVICE WAS USED TO REMOVE THE FOREIGN BODY FROM THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18441103 ↗
  • InjuryJan 3, 2024Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, AN IMPRESS CATHETER TIP DETACHED WITHIN THE PATIENT'S VENOUS SYSTEM. THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE FRACTURED PIECES FROM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18441096 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page