Impress® 00884450020043Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450020043), received between Apr 3, 2020 and Oct 31, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A THORACIC AORTIC ANEURYSM PROCEDURE THE TIP OF THE CATHETER DETACHED WITHIN THE AORTIC ARCH. THE DETACHED PORTION WAS PULLED INTO A SHEATH, AND IT WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. NO PATIENT INJURY. THE OPERATING PHYSICIAN STATED THAT THE CATHETER WAS BROUGHT FORWARD WITH EXCESSIVE FORCE WITHIN VESSEL WITH SIGNIFICANT CURVATURE AND TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038406 ↗
• InjuryAug 14, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOPLASTY THE CATHETER BROKE DURING REMOVAL OF THE DEVICE IN THE ILIAC ARTERY. A SNARE WAS USED TO REMOVE THE TIP FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546913 ↗
• InjuryOct 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE CLINICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED PIECE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552543 ↗
• InjuryAug 5, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE FOR A PERIPHERAL CHRONIC TOTAL OCCLUSION [CTO], THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS WITHIN THE VESSEL, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODIES FROM THE PATIENT. ANOTHER SHEATH WAS PLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10370760 ↗
• InjuryJul 9, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10254321 ↗
• InjuryApr 23, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION [SFACTO] PROCEDURE, THE CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS AND WAS ATTEMPTING TO MANIPULATE THE CATHETER TO THE DISTAL SIDE OF A SUPERFICIAL STENOTIC LESION WHEN THE CATHETER TIP DETACHED. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT'S PERIPHERY WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9993229 ↗
• InjuryApr 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND THE 4F CATHETER. DURING CATHETER MANIPULATIONS OVER THE WIRE WITHIN THE PATIENT'S AORTIC BIFURCATION THE CATHETER TIP DETACHED. A CONTRALATERAL FEMORAL RETROGRADE ARTERIAL ACCESS WAS NECESSARY TO SUCCESSFULLY RETRIEVE THE BROKEN TIP WITH A VASCULAR SNARE DEVICE. THE SECONDARY ACCESS SITE RESULTED IN A FALSE ANEURYSM WHICH MADE A SECONDARY PROCEDURAL INTERVENTION NECESSARY WITHIN THE SURGICAL ARENA UNDER GENERAL ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920866 ↗