Impress® 00884450661567Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450661567), received between Jul 2, 2024 and Jul 2, 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.

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 2, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A CATHETER TIP FRAGMENTED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP FRAGMENTED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE IATROGENIC FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657327 ↗
• InjuryJul 2, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A CATHETER TIP DETACHED WHILE ADVANCING THE CATHETER OVER THE INTERVENTIONAL GUIDEWIRE EX VIVO UNDER FLUOROSCOPY. THE CATHETER WAS REMOVED FROM THE GUIDEWIRE AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE FOR THIS PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657323 ↗