Impress® 00884450009277Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450009277), received between May 12, 2022 and Jul 7, 2022 — 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.

Most reported problems

Recent adverse event reports

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

• InjuryJul 7, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE DEVICE BROKE AND REMAINED IN THE RADIAL ARTERY WHEN THE CATHETER WAS WITHDRAWN FROM THE PATIENT. AN ADDITIONAL SURGERY WAS REQUIRED. MEDICAL INTERVENTION WAS REQUIRED. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945582 ↗
• InjuryMay 12, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY [PTA] PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE RADIAL ARTERY ACCESS AND WHEN ATTEMPTING TO ADVANCE THE CATHETER OVER A GUIDEWIRE, THE CLINICAL STAFF NOTED THAT THE CATHETER TIP WAS DAMAGED. THE PHYSICIAN CONTINUED TO NAVIGATE THE PATIENT'S BRACHIAL ARTERY UNDER FLUOROSCOPY WHEN THE TIP DETACHED. THE FOREIGN BODY MIGRATED TO THE PROXIMAL END OF THE PATIENT'S RADIAL ARTERY. AFTER FURTHER ASSESSMENT OF THE PATIENT'S CONDITION POST PROCEDURE, THE PHYSICIAN DECIDED NOT TO ATTEMPT THE REMOVAL OF THE FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14374822 ↗