Impress® 00884450035948Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884450035948), received between Apr 22, 2021 and Oct 31, 2023 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER ALLEGES THAT DURING A VENOGRAM, THE EXPIRED CATHETER TIP DETACHED WITHIN THE PATIENT WHILE REMOVING THE CATHETER OVER THE A GUIDEWIRE. NO ADDITIONAL PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040082 ↗
• MalfunctionJun 13, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE REMOVING THE CATHETER IT DISLODGED AT THE TIP OF THE SHEATH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115178 ↗
• MalfunctionOct 27, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ARTERIAL ACCESS PROCEDURE, THE TIP OF THE CATHETER BROKE OFF. THE PROVIDER USED A SNARE TO OBTAIN THE BROKE PIECE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12703702 ↗
• MalfunctionOct 27, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ARTERIAL ACCESS PROCEDURE, THE TIP OF THE CATHETER BROKE OFF. THE PROVIDER USED A SNARE TO OBTAIN THE BROKE PIECE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12703700 ↗
• InjuryOct 19, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A ROUTINE ANGIOPLASTY PROCEDURE, THE TIP OF THE CATHETER BROKE OFF AND REMAINED IN THE ARTERY OVER THE AMPLATZ WIRE. THE PROVIDER USED A SNARE TO OBTAIN THE BROKE PIECE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12657570 ↗
• InjuryOct 19, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A ROUTINE ANGIOPLASTY PROCEDURE, THE TIP OF THE CATHETER BROKE OFF AND REMAINED IN THE ARTERY OVER THE AMPLATZ WIRE. THE PROVIDER USED A SNARE TO OBTAIN THE BROKE PIECE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12657562 ↗
• InjuryJun 16, 2021Fracture; Material Separation; Fracture; Material Separation

  WHILE GAINING ARTERIAL ACCESS FOR A NEPHROSTOMY, THE IMPRESS CATHETER DETACHED WHEN INSERTING A GUIDE WIRE INTO THE CATHETER WHILE THE CATHETER WAS IN-VIVO. A SNARE WAS NEEDED TO RETRIEVE THE CATHETER FRAGMENT. A STANDARD 150CM STRAIGHT TIP GUIDEWIRE WAS USED FOR THE PROCEDURE. NO TORTUOUS, DISEASED, OR CALCIFIED ANATOMY TO REPORT. NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12009804 ↗
• MalfunctionJun 16, 2021Fracture; Material Separation; Fracture; Material Separation

  DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, THE IMPRESS CATHETER DETACHMENT OCCURRED WHEN THE DOCTOR STATED HE FELT SOMETHING STRANGE, [TACTILE FEELING] DURING GUIDEWIRE INSERTION. THE CATHETER AND THE GUIDEWIRE WERE BOTH REMOVED BEFORE TOTAL DETACHED WITHIN THE PATIENT. A STANDARD 150CM STRAIGHT TIP GUIDEWIRE WAS USED BOTH PROCEDURES. NO TORTUOUS, DISEASED, OR CALCIFIED ANATOMY TO REPORT. NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12009788 ↗
• InjuryMay 19, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY REPLACEMENT PROCEDURE, THE TIP OF THE CATHETER BROKE OFF AND REMAINED INSIDE THE PATIENT. SNARE WAS USED TO REMOVE THE TIP OF THE CATHETER FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11849563 ↗
• InjuryApr 22, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR ANEURISM REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED BILATERAL FEMORAL VASCULAR ACCESS. DURING GUIDE CATHETER REMOVAL THE CATHETER TIP DETACHMENT WAS NOTED. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712523 ↗
• InjuryApr 22, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR ANEURISM REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED BILATERAL FEMORAL VASCULAR ACCESS. DURING GUIDE CATHETER REMOVAL THE CATHETER TIP DETACHMENT WAS NOTED. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712472 ↗