Impress® 00884450030134Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450030134), received between Oct 5, 2021 and Dec 17, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Fracture; Fracture

  ACCOUNT REPORT THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR ABDOMINAL AORTIC ANEURYSM. THE OPERATOR INSERTED THE IMPRESS CATHETER ALONG THE RADIFOCUS¿ GUIDE WIRE. THAT WIRE WAS EXCHANGED FOR THE LUNDERQUIST WIRE. WHILE ATTEMPTING TO REMOVE THE IMPRESS CATHETER, IT'S TIP (APPROXIMATELY 10 CM IN LENGTH) BROKE OFF. ATTEMPTS TO RETRIEVE THE TIP WERE UNSUCCESSFUL AND THE PROCEDURE WAS TERMINATED WITH THE BROKEN FRAGMENT REMAINING BETWEEN THE STENT GRAFT AND THE ANEURYSM WALL, INSIDE THE ANEURYSM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23830640 ↗
• InjuryJan 3, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR THROMBECTOMY [EVT] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE CATHETER WAS INSERTED VIA THE FEMORAL ARTERY, AND THE DETACHMENT OCCURRED WITHIN A LOWER EXTREMITY ARTERY. THE VESSEL HAD ARTERIOSCLEROSIS, AND THE PATIENT HAS RECEIVED THE EVT PROCEDURE REPEATEDLY IN THE PAST. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO RETRIEVE FRACTURED PIECES FROM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441104 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE, THE TIP OF THE CATHETER DETACHED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882949 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE, THE TIP OF THE CATHETER DETACHED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882894 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE, THE TIP OF THE CATHETER DETACHED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882891 ↗
• InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE, THE TIP OF THE CATHETER DETACHED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882863 ↗
• InjurySep 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A 60YO MALE PRESENTED WITH A FALL FROM 2 METERS. A PELVIC CT STUDY DEMONSTRATED A FRACTURE WITH ARTERIAL INJURIES. PATIENT WAS ADMITTED AND SENT FOR ANGIOGRAM. AN 18G ACCESS NEEDLE WAS ADVANCED INTO RIGHT CFA FOLLOWED BY 5F 10CM INTRODUCER SHEATH. AN 0.035" 150CM GUIDEWIRE AND A 5F CATHETER WERE USED FOR LEFT IIA ANGIOGRAM PROCEDURE. A PSEUDOANEURYSM AND AV FISTULA FROM LEFT SUPERIOR GLUTEAL ARTERY WAS NOTED. SUPER-SELECTIVE ANGIOGRAMS OF VARIOUS BRANCHES OF LEFT SUPERIOR GLUTEAL ARTERY BY USING 2.0F MICROCATHETER WITH 0.016" GUIDEWIRE. THE MICROCATHETER 2.0F WAS EXCHANGED TO A 4F AND 1.98F SOFT CATHETER DUE TO INADEQUATE COIL SUPPORT. A COIL EMBOLIZATION WAS PERFORMED TO CONTROL BLEEDING BY USING 19 COILS VIA 1.98F VIA THE 4F CATHETER. THE CATHETER TIP WAS ADVANCED TO PROXIMAL PART OF LEFT SUPERIOR GLUTEAL ARTERY. AFTER COMPLETING THE COIL EMBOLIZATION PROCEDURE, THE 4F CATHETER WAS PULLED BACK, ABOUT 3 CM, DSA WAS PERFORMED. THE 4F CATHETER TIP DETACHED WITHIN THE PATIENT. A VASCULAR SNARE WAS USED TO ATTEMPT REMOVAL OF THE RETAINED CATHETER, BUT IT KEPT CUTTING THE FOREIGN BODY INTO SMALL PIECES. THE RESIDUAL PORTION OF THE CATHETER TIP WAS PUSHED DEEPER

  Patient problems: Foreign Body In Patient

  MAUDE report 15336339 ↗
• InjuryOct 5, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF A CATHETER BROKE OFF INSIDE THE PATIENT. THE PATIENT HAD CHALLENGING ANATOMY WITH SEVERE BLOCKAGES DUE TO CALCIUM. THE PROVIDER NOTICED THAT THE TIP SEPARATED DURING HIS MANEUVERS. THE CATHETER WAS STILL OVER THE WIRE SO THE DOCTOR WAS ABLE TO SNARE THE BROKEN CATHETER TIP AND REMOVE FROM THE BODY WITHOUT ANY COMPLICATIONS. NO PATIENT INJURY AND NO COMPLICATIONS DUE TO CATHETER BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12576890 ↗