Impress® 00884450022436Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884450022436), received between Oct 25, 2019 and Oct 31, 2023 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 14 most recent of 14 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 TEVAR PROCEDURE, A THORACIC STENT GRAFT WAS PLACED, AND AFTER THE PIG TAIL CATHETER WAS BROUGHT FORWARD FROM RIGHT FEMORAL ARTERY TO THE TARGET SITE ALONG A RADIFOCUS GUIDEWIRE, THEN ANGIOGRAPHY WAS PERFORMED. THE RIGHT FA HAD CALCIFICATION. CATHETER REMOVAL WAS THEN ATTEMPTED POST ANGIOGRAPHY, AND IT WAS FOUND THAT THE TIP HAD DETACHED. DETACHMENT WAS AT THE LEVEL OF CELIAC ARTERY IN THE AO. THE TIP MIGRATED TO THE DISTAL END OF THE DEPLOYED STENT GRAFT. THE FRAGMENT WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038407 ↗
• InjuryMar 2, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE CATHETER TIP CRACKED AND SEPARATED FROM THE REST OF THE DEVICE. THE CLINICIAN USED A CAPTURE DEVICE TO SUCCESSFULLY RETRIEVE THE FRAGMENT FROM THE PATIENT. NO ADDITIONAL INJURY ON PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13656803 ↗
• InjuryOct 25, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TUNNELED DIALYSIS CATHETER PLACEMENT PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE CLINICIAN HAD ACQUIRED ANTEGRADE ACCESS WITHIN THE PATIENT'S INTERNAL JUGULAR VEIN AND WHILE ATTEMPTING TO CANNULATE THE PATIENT SUPERIOR VENA CAVA [SVC] WITH THE GUIDEWIRE THE CATHETER TIP DETACHED. THE CLINICIAN EXTERNALIZED THE FOREIGN BODY TOGETHER WITH THE GUIDEWIRE LIBERATING THE SVC. NO ADDITIONAL INTERVENTIONAL PROCEDURE WAS NECESSARY. ANOTHER GW AND CATHETER WAS PREPPED TO SUCCESSFULLY COMPLETE THIS PROCEDURE. ONLY A SMALL DELAY IN PROCEDURE TO REPORT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692465 ↗
• MalfunctionOct 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL INTRAVASCULAR PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665612 ↗
• MalfunctionOct 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A TUNNELED DIALYSIS CATHETER PLACEMENT PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE CLINICIAN HAD ACQUIRED ANTEGRADE ACCESS WITHIN THE PATIENT'S INTERNAL JUGULAR VEIN AND WHILE ATTEMPTING TO CANNULATE THE PATIENT SUPERIOR VENA CAVA [SVC] WITH THE GUIDEWIRE THE CATHETER TIP DETACHED. THE CLINICIAN EXTERNALIZED THE FOREIGN BODY TOGETHER WITH THE GUIDEWIRE LIBERATING THE SVC. NO ADDITIONAL INTERVENTIONAL PROCEDURE WAS NECESSARY. ANOTHER GW AND CATHETER WAS PREPPED TO SUCCESSFULLY COMPLETE THIS PROCEDURE. ONLY A SMALL DELAY IN PROCEDURE TO REPORT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665607 ↗
• MalfunctionOct 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL INTRAVASCULAR PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665596 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128578 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128571 ↗
• MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT WHILE PRIMING THE PM SET, LEAKAGE WAS SEEN. THE DEVICE WAS SWITCHED OUT FOR ANOTHER. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009824 ↗
• MalfunctionJan 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT THE TIP OF AN IMPRESS PIGTAIL CATHETER HAD DETACHED DURING CATHETER WITHDRAWAL UNDER FLUOROSCOPY, THROUGH THE COMMON ILIAC ARTERY [CIA] DURING AN EVAR PROCEDURE. THE PHYSICIAN HAD TO UPSIZE THE ACCESS SHEATH TO SUCCESSFULLY RETRIEVED THE TIP FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132771 ↗
• MalfunctionDec 21, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN STATES THAT THE CATHETER DETACHED BETWEEN A RADIOPAQUE MARKER AND THE TIP OF THE SHAFT DURING CATHETER WITHDRAWAL. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE DETACHED CATHETER TIP BY HAND. NO FURTHER INTERVENTION WAS REQUIRED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051623 ↗
• InjuryOct 27, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAM, THE PIG TAIL CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING A TARGETED POWER INJECTION, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN THEN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. A NEW CATHETER WAS PREPPED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742947 ↗
• MalfunctionApr 9, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE THE TIP OF A PIGTAIL CATHETER ALMOST DETACHED. THE DEVICE WAS REPLACED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9945994 ↗
• MalfunctionOct 25, 2019Break; Fracture; Material Separation; Break; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS AND HAD SUCCESSFULLY CROSSED THE TARGETED ARTERIAL LESION. DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE THE TIP DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY CAPTURE AND REMOVE THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242432 ↗