Impress® 00884450688236Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450688236), received between Jan 9, 2026 and Jan 20, 2026 — classified as 1 death, 1 malfunction.

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.

• MalfunctionJan 20, 2026Break; Fracture; Material Fragmentation; Material Separation

  THE ACCOUNT ALLEGES THAT PRIOR TO USE, THE TIP OF THE DIAGNOSTIC CATHETER WAS FOUND TO BE DETACHED WITHIN THE PACKAGING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119188 ↗
• DeathJan 9, 2026Fracture; Material Fragmentation; Material Separation

  THE ACCOUNT ALLEGES THAT A 71-YEAR-OLD MALE WITH SIGNIFICANT COMORBIDITIES UNDERWENT EMERGENCY AORTOGRAPHY ON (B)(6) 2025, FOR SUSPECTED MESENTERIC ARTERIAL ISCHEMIA. THE PATIENT WAS CRITICALLY ILL PRIOR TO THE PROCEDURE, WITH HEMODYNAMIC INSTABILITY, INTUBATION, AND VASOACTIVE SUPPORT. DURING REMOVAL OF THE GUIDEWIRE AND EXIT OF THE PIGTAIL CATHETER FROM THE INTRODUCER, FRAGMENTATION OF THE CATHETER TIP WAS IDENTIFIED UNDER FLUOROSCOPY. NO IRREGULARITIES WERE OBSERVED PRIOR TO USE. THE BLACK PIGTAIL SEGMENT FRAGMENTED DURING RETRIEVAL, RESULTING IN FIVE FRAGMENTS; ONE WAS RECOVERED, AND FOUR EMBOLIZED TO THE LEFT HYPOGASTRIC ARTERY AND LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. SNARE-BASED RETRIEVAL WAS ATTEMPTED WITH PARTIAL SUCCESS; COMPLETE EXTRACTION WAS NOT POSSIBLE. DUE TO THE PATIENT'S DETERIORATING CONDITION, NO FURTHER INTERVENTION WAS PERFORMED AT THAT TIME. ANOTHER CATHETER FROM THE SAME LOT FRAGMENTED UPON REMOVAL FROM THE PACKAGING DURING THE SAME PROCEDURE. THE PATIENT DIED ON (B)(6) 2025. CAUSE OF DEATH WAS DOCUMENTED AS MULTI-ORGAN FAILURE. THE ATTENDING PHYSICIAN STATED THAT THE CATHETER FRAGMENTATION WAS NOT THE ULTIMATE CAUSE OF DEATH BUT CONTRIBUTED BY DELAYING

  Patient problems: Foreign Body In Patient

  MAUDE report 24021718 ↗