Impress® 00884450020449Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884450020449), received between Nov 2, 2021 and Dec 14, 2021 — classified as 7 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT UPON PULLING THE CATHETER FROM THE PATIENT IT WAS NOTICED THAT THE TIP HAD DETACHED WITHIN THE COMMON ILIAC ARTERY. X-RAY CONFIRMED THE TIP WITHIN THE PATIENT. TO DATE IT IS UNKNOWN IF THE TIP WAS REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13005440 ↗
• InjuryDec 8, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION PROCEDURE THE TIP OF THE CATHETER BROKE INTO THREE PIECES. THE PIECES WERE RETRIEVED USING A SNARE THROUGH THE LEFT FEMORAL ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12961465 ↗
• InjuryNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE TIP OF THE CATHETER ALMOST DETACHED FROM THE CATHETER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888332 ↗
• InjuryNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAPHY PROCEDURE WHERE COIL EMBOLIZATION AND STENTGRAFT PLACEMENT WAS BEING PERFORMED IN AN INTERNAL ILIAC ARTERY, THE TIP OF THE CATHETER DETACHED FROM THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12888322 ↗
• MalfunctionNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A AN ABCESS DRAIN REPOSITIONING PROCEDURE UNDER FLUOROSCOPIC GUIDANCE, THE TIP OF THE CATHETER BROKE BUT DID NOT COMPLETELY SEPARATE FROM THE CATHETER SHAFT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888318 ↗
• InjuryNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE TIP OF THE CATHETER DETACHED FROM THE CATHETER. THE TIP WAS NOT RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12888315 ↗
• MalfunctionNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY CATHETER CONVERSION TO NEPHROURETERAL CATHETER UNDER FLUOROSCOPIC GUIDANCE, THE TIP OF THE CATHETER BROKE BUT DID NOT COMPLETELY SEPARATE FROM THE CATHETER SHAFT. THE DEVICE WAS SWITCHED OUT FOR A NEW ONE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888288 ↗
• MalfunctionNov 29, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A LOWER EXTREMITY ANGIOGRAM, THE TIP OF THE CATHETER COMPLETELY SEPARATE FROM THE CATHETER SHAFT WHILE DOWN THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY. THE TIP WAS STILL ON THE WIRE DISTAL TO THE SHEATH TIP AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND THE PROCEDURE ABORTED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888283 ↗
• InjuryNov 9, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAM, THE TIP OF THE CATHETER SEPARATED WHILE INSIDE THE PATIENT. A SHEATH EXCHANGE WAS PERFORMED AND THE TIP REMOVED WITH A SNARE. NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 12780945 ↗
• InjuryNov 2, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN THE CATHETER WAS INSERTED INTO PATIENT THE TIP BROKE OFF INSIDE THE PATIENT'S VESSEL. THE PROVIDER USED A SNARE TO RETRIEVE IT. THERE WERE NO PATIENT INJURY THROUGHOUT THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12741229 ↗