Impress® 00884450009253Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450009253), received between Nov 13, 2020 and Dec 13, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LOWER LIMB BALLOON DILATION PROCEDURE, THE TIP OF THE CATHETER DETACHED. THIS OCCURRED AFTER THE ANGIOGRAPHY DURING REMOVAL OF THE CATHETER. THE BROKEN FRAGMENTS WERE REMOVED WITH A SNARE AND PRE-KEY DELIVERY SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973999 ↗
• InjuryNov 3, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE OF A LOWER LIMB, THE DISTAL END OF THE CATHETER DETACHED WITHIN THE PATIENT. 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 15721821 ↗
• MalfunctionNov 9, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR AORTIC REPAIR [EVAR] PROCEDURE, THE CATHETER TIP STARTED TO DETACH WITHIN THE PATIENTS AORTOILIAC BIFURCATION. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED BILATERAL FEMORAL ARTERY ACCESS. A GUIDEWIRE WAS THEN ADVANCED FROM THE IPSILATERAL RIGHT ILIOFEMORAL SIDE TO THE CONTRALATERAL LEFT SIDE. THE DAMAGED CATHETER WAS IDENTIFIED VIA FLUOROSCOPY AND WAS CAPTURED WHILE STILL ON THE GUIDEWIRE WITH A VASCULAR SNARE DEVICE. THE DAMAGED CATHETER WAS SUCCESSFULLY EXTERNALIZED VIA THE CONTRALATERAL SIDE, NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781046 ↗
• InjuryNov 9, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CEREBRAL VENOGRAPHY WITH POSSIBLE ANGIOPLASTY PROCEDURE, THE 5F CATHETER TIP DETACHED WITHIN THE PATIENT'S VENOUS SYSTEM. DUE TO THE LOCATION AND SIZE OF THE FOREIGN BODY, THE TIP COULD NOT BE SUCCESSFULLY REMOVED. THE FOREIGN BODY WAS TOO DIFFICULT TO REACH, THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY WITHIN THE PATIENT. THE PATIENT IS UNDER OBSERVATION AND IS IN STABLE CONDITION WITH NO ADDITIONAL RELATED COMPLICATIONS TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12781043 ↗
• MalfunctionDec 15, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING A PERIPHERAL VASCULAR SELECTIVE ABDOMINAL ANGIOGRAM [THIRD ORDER] OF THE LOWER ABDOMINAL EXTREMITIES FOR DEPLOYMENT OF A RIGHT RENAL ARTERY STENT, WHEN THE CATHETER TIP KINKED AND DETACHED. THE PHYSICIAN HAD ACQUIRED OPEN UNILATERAL SUBCLAVIAN ARTERY ACCESS FOR DELIVERY OF ENDOVASCULAR PROSTHESIS [STENT] VIA INFRACLAVICULAR OR SUPRACLAVICULAR INCISION. A 12F SHEATH WAS SUCCESSFULLY PLACED. THROUGH THE 12F SHEATH A STEERABLE SHEATH WAS PLACED AND A 100 CM 5F DIAGNOSTIC CATHETER WAS INTRODUCED. THE PHYSICIAN STATES THAT A SIGNIFICANT AMOUNT OF TORQUE WAS PLACED ON THE STEERABLE SHEATH WHEN IT KINKED. WHEN THE PHYSICIAN TRIED TO REMOVE THE DIAGNOSTIC CATHETER THE FIRST 12-20 CM DETACHED AT THE KINK AND REMAINED WITHIN THE STEERABLE SHEATH. THE STEERABLE SHEATH WAS REMOVED TOGETHER WITH THE CATHETER TIP AND PASSED OFF THE STERILE FIELD. THE PATIENT TOLERATED THE PROCEDURE WELL. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013421 ↗
• MalfunctionNov 13, 2020Break; Deformation Due to Compressive Stress

  PER THE SURGEON'S EXPLANATION OF EVENT: THE LEFT AXILLARY ARTERY WAS EXPOSED AND A 12 FR SHEATH WAS PLACED. THROUGH THE 12 FR SHEATH A NEGARE STEERABLE SHEATH WAS PLACED AND A 100 CM BERENSTEIN CATHETER WAS PLACED THROUGH IT. I HAD TO GENERATE SIGNIFICANT AMOUNT OF TORQUE ON THE SHEATH AND IT KINKED. WHEN I TRIED TO REMOVE THE BERENSTEIN CATHETER THE FIRST 15-20 CM OF CATHETER BROKE AT THE KINK AND STAYED IN THE NEGARE. THE NEGARE WAS REMOVED WITH THE CATHETER TIP INSIDE AND PASSED OFF OF THE STERILE FIELD.

  Patient problems: Insufficient Information

  MAUDE report 10835797 ↗