Impress® 00884450038185Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884450038185), received between Oct 10, 2019 and Dec 2, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE BLACK TIP OF THE IMPRESS CATHETER FRACTURED DURING STENT DELIVERY IN A HIGHLY TORTUOUS LESION. THE BROKEN FRAGMENT WAS RETRIEVED USING A SNARE AND THE DEVICE HAS BEEN DISCARDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693963 ↗
• InjuryJan 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT WHILE MANEUVERING THE DEVICE WITHIN THE UTERINE ARTERY FOR ARTERIOVENOUS MALFORMATION. THE DETACHED TIP WILL BE RETRIEVED USING A SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16092044 ↗
• InjurySep 30, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR ANGIOGRAM OF A PATIENT'S RIGHT LEG, THE CATHETER TIP DETACHED. THE CLINICIAN HAD ACQUIRED LEFT RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S STEEP ILIO-FEMORAL CONDUIT WITH A GUIDEWIRE AND THE 5F CATHETER. DURING AN OVER-THE-WIRE CATHETER EXCHANGE WITHIN THE PATIENT'S CALCIFIED ILIAC BIFURCATION, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY VIA BILATERAL FEMORAL ARTERY ACCESS THUS LIBERATING THE VESSEL. THE FOREIGN BODY RETRIEVAL WAS COMPLICATED BY A THROMBOGENIC REACTION CAUSED BY THE DETACHED FOREIGN BODY WITH THROMBOSIS NOTED WITHIN THE COMMON ILIAC, EXTERNAL ILIAC, AND THE PROFUNDA ARTERIES. THE PATIENT WAS PUT ON HEPARIN INFUSION OVERNIGHT, HOWEVER DUE TO THE CONTINUED ISCHEMIC COMPLICATIONS, THE ADVERSE EVENT RESULTED IN A BELOW KNEE AMPUTATION.

  Patient problems: Foreign Body Embolism; Thrombosis/Thrombus

  MAUDE report 15510357 ↗
• InjuryJul 27, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE CATHETER FRACTURED WHILE IN THE UPPER GLUTEAL ARTERY. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114727 ↗
• MalfunctionJul 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ILIAC ANGIOPLASTY, THE TIP OF THE CATHETER BROKE OFF AND WITHIN THE PATIENT. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008246 ↗
• InjuryJun 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN AAA AND EVAR PROCEDURE, THE CATHETER FRACTURED AND A PORTION OF IT HAD TO BE RETRIEVED WITH A SNARE AS THE PHYSICIAN TRIED TO REMOVE THE CATHETER FROM THE SHEATH OVER THE WIRE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861097 ↗
• InjuryMay 19, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A RENAL ARTERIOGRAPHY PROCEDURE, THE TIP OF THE CATHETER WAS FOUND DETACHED AS THE CATHETER WAS REMOVED. THE PHYSICIAN USED A CAPTURE DEVICE TO REMOVE THE DETACHED TIP. NO ADDITIONAL PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14439035 ↗
• InjuryApr 27, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER DETACHED SUBINTIMAL BEHIND CALCIFIED PLAQUE DURING CATHETER MANIPULATIONS. AFTER REMOVING THE GUIDEWIRE AND INJECTING CONTRAST MEDIA, IT BECAME AWARE THAT THE TIP HAD DETACHED. RETRIEVAL OF THE TIP IS NOT POSSIBLE WITHOUT SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223163 ↗
• InjuryMar 16, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE DEVICE BROKE OFF WITHIN THE PATIENT'S AORTA. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778732 ↗
• InjuryJan 19, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND DURING OVER-THE-WIRE CATHETER MANIPULATIONS WITHIN THE PATIENTS UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290625 ↗
• InjuryJan 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] WITH STENT PLACEMENT PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT'S BRACHIAL ARTERY. THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS ANESTHETIZED FOR A SURGICAL FOREIGN BODY EXTRACTION. SURGICALLY THE PHYSICIAN WAS SUCCESSFUL IN EXTERNALIZING THE FOREIGN BODY FROM THE PATIENT'S BRACHIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181468 ↗
• InjuryDec 21, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING VASCULAR PROCEDURE, THE TIP OF THE 5F CATHETER DETACHED. THE PHYSICIAN WAS REMOVING THE CATHETER OVER A GUIDE WIRE THROUGH A STANDARD SHEATH. THE TIP WAS SUCCESSFULLY RETRIEVED FORM THE PATIENT WITH NO ADDITIONAL INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051622 ↗
• MalfunctionOct 10, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE THE CATHETER TIP BROKE INTO SMALL PIECES. NO ADDITIONAL PROCEDURES/INTERVENTIONS WERE NEEDED FOR THIS PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Information

  MAUDE report 9176891 ↗
• MalfunctionOct 10, 2019Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT APPROXIMATELY ONE-MONTH POST DIALYSIS CATHETER IMPLANT; THE CATHETER WAS LEAKING. THE PATIENT RETURNED TO THE CLINIC FOR CATHETER REPLACEMENT. NO INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176890 ↗