Impress® 00884450646533Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884450646533), received between Mar 6, 2023 and Jun 20, 2023 — classified as 9 injuries, 2 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.

• InjuryJun 20, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN AVF PROCEDURE, THE TIP OF THE CATHETER WAS DETACHED IN PATIENT BODY. IMMEDIATELY, THE PATIENT TRANSFERRED TO (B)(6) HOSPITAL TO RETRIEVE DETACHED TIP BY THE INTERVENTIONAL TEAM. THE DETACHED TIP WAS RETRIEVED WITH SNARE SUCCESSFULLY. THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17167815 ↗
• MalfunctionMay 17, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PTA PROCEDURE, THE PHYSICIAN FELT THAT THERE WAS A SOMETHING STRANGE WITH CATHETER. SO PHYSICIAN REMOVED IT FROM THE PATIENT'S BODY AND DISCOVERED THE TIP WAS PARTIALLY DETACHED AND THEN COMPLETELY DISCONNECTED WHILE EXAMINING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947019 ↗
• InjuryMar 24, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE CATHETER BROKE OFF WITHIN THE PATIENT. THE TIP COULD NOT BE SUCCESSFULLY RETRIEVED AND REMAINS WITHIN THE PULMONARY ARTERY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16611481 ↗
• InjuryMar 24, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE CATHETER BROKE OFF WITHIN THE PATIENT. THE TIP WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611470 ↗
• InjuryMar 22, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE TIP OF THE CATHETER BROKE OFF WITHIN THE PATIENT. THE TIP WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591286 ↗
• InjuryMar 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING EVALUATION OF AN ARTERY IN THE PATIENT'S UPPER EXTREMITY FOR DIALYSIS TREATMENT, THE TIP OF THE CATHETER DETACHED WITHIN THE SUBCLAVIAN ARTERY. A SIMPLE BENSTON WIRE WAS USED FOR DELIVERABILITY. A STIFF GUIDWIRE WAS NOT USED FOR THIS PROCEDURE. NO TORTUOUS, DISEASED, OR CALCIFIED ARTERIES WERE NOTED DURING THE PROCEDURE, THE DETACHED CATHETER TIP WAS EASILY RETRIEVED WITH A SNARE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586230 ↗
• InjuryMar 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING EVALUATION OF AN ARTERY IN THE PATIENT'S UPPER EXTREMITY FOR DIALYSIS TREATMENT, THE TIP OF THE CATHETER DETACHED WITHIN THE BRACHIAL ARTERY. A SIMPLE BENSTON WIRE WAS USED FOR DELIVERABILITY. A STIFF GUIDWIRE WAS NOT USED FOR THIS PROCEDURE. NO TORTUOUS, DISEASED, OR CALCIFIED ARTERIES WERE NOTED DURING THE PROCEDURE, THE DETACHED CATHETER TIP WAS EASILY RETRIEVED WITH A SNARE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586202 ↗
• InjuryMar 6, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING KUMPE CATHETERIZATION OF THE RADIAL ARTERY, THE CATHETER TIP SHEARED OFF INTO THE RADIAL ARTERY. USING A SNARE DEVICE, THE TIP WAS RETRIEVED AND REMOVED FROM THE PATIENT'S ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492616 ↗
• MalfunctionMar 6, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING FISTULAGRAM WITH ANGIOPLASTY ON THE PATIENT'S RUAF, THE TIP OF THE CATHETER BROKE. THE TIP DID NOT DETACH. OPENED ANOTHER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492615 ↗
• InjuryMar 6, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UFE PROCEDURE, THE TIP OF THE CATHETER BROKE OFF. PHYSICIAN SNARED IT OUT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492613 ↗
• InjuryMar 6, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP BECAME DISLODGED IN THE PATIENTS ARM DURING A FISTULAGRAM. THE TIP CAN BE SEEN VIA XRAY. NO PATIENT HARM AT TIME OF REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16492609 ↗