Impress® 00884450009451Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450009451), received between Aug 3, 2022 and Oct 24, 2023 — classified as 6 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 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 24, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PROCEDURE AND WITHIN THE AORTIC ARCH, THE CATHETER WAS ROTATED TO RESHAPE THE SIM WITH RELATIVE EASE DUE TO PATIENT ANATOMY. ONCE TURNED IT WAS NOTED THAT THE ENTIRE TIP OF THE CATHETER HAD DETACHED. CATHETER AND WIRE PULLED INTO INFERIOR RENAL AORTA. SECOND SHEATH PACED INTO THE RIGHT FEMORAL ARTERY WHERE AN A SNARE DEVICE WAS USED TO ATTEMPT TO REMOVE THE DETACHED TIP. TIP DISLODGED AND TRAVELED TO THE LEFT ILIAC ARTERY WHERE IT WAS SNARED. ONCE THE TIP WAS SNARED IT SNAPPED AND AROUND 8CM OF THE DEVICE MIGRATED TO THE PROFUNDA ARTERY. A PORTION OF THE CATHETER WAS REMOVED WHILE THE REMAINING TIP LEFT IN PLACE. REFERRAL TO VASCULAR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000173 ↗
• InjuryOct 17, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN THE CATHETER WAS INSERTED INTO THE FEMORAL ARTERY, IT WAS FOUND THE TIP OF CATHETER WAS CRACKED AND ALL PIECES WERE REMOVED FROM PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954497 ↗
• InjurySep 4, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION PROCEDURE OF THE LEFT INTERNAL ILIAC ARTERY FOR AN EVAR PROCEDURE, THE CATHETER TIP DETACHED WHILE WITHIN THE VESSEL. THE TIP WAS RETRIEVED WITH A SNARE. THE CATHETER WAS USED AS A PASSAGE FOR DELIVERY OF THE EMBOLICS. IT WAS INSERTED INTO THE LEFT COMMON FEMORAL ARTERY AND BROUGHT RETROGRADE THROUGH THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT EIA HAD TORTUOSITY BUT NO CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680512 ↗
• MalfunctionJan 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERNAL INLIAC ARTERY PROCEDURE, THE CATHETER WAS BEING WITHDRAWN AND THE TIP WAS FOUND TO BE DISCONNECTED. THE DETACHED TIP WAS WITHIN THE SHEATH AND WAS EASILY RETRIEVED WITH THE SHEATH. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092066 ↗
• InjuryDec 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING ENDOVASCULAR PROCEDURE ON A PATIENT DIAGNOSED WITH A PULMONARY EMBOLISM [PE]. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED VASCULAR ACCESS AND DURING CATHETER MANIPULATIONS THE CATHETER TIP DETACHED WITH THE PATIENT. THE CLINICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE PATIENT TOLERATED THE PROCEDURE WELL AND ANOTHER CATHETER WAS USED TO SUCCESSFULLY COMPLETE THIS PROCEDURE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941590 ↗
• InjuryOct 7, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A STENTGRAFT PROCEDURE WITH COIL EMBOLIZATION IN THE INTERNAL ILIAC ARTERY, THE TIP OF THE CATHETER BROKE DURING APPAROCH TO THE RIGHT INTERNAL ILIAC ARTERY. THE PHYSICIAN DECIDED THAT THE TIP COULD NOT BE RETRIEVED WITH SNARE DUE TO BEING STUCK WITHIN THE VESSEL. AS OF THE DATE OF THIS REPORT, THE TIP REMAINS WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15560190 ↗
• InjuryAug 3, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND WAS ATTEMPTING TO NAVIGATE THE VASCULAR SYSTEM TO DELIVER A GUIDEWIRE TO THE PATIENT'S INFERIOR MESENTERIC ARTERY (IMA). AN 0.035 GUIDEWIRE WAS INSERTED INTO THE CATHETER AND AN ATTEMPT TO CANNULATE THE IMA WAS MADE WITH NO SUCCESS. THE GUIDEWIRE WAS EXCHANGED FOR AN .014 GUIDEWIRE. DURING CATHETER MANIPULATIONS OVER THE .014 GUIDEWIRE THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161210 ↗