Impress® 00884450026571Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450026571), received between Dec 20, 2019 and Aug 21, 2020 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DIAGNOSTIC PROCEDURE, A CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE, ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS WITHIN THE PATIENT THE 4F CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE WITHOUT ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10440064 ↗
• MalfunctionAug 5, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION ACQUIRING THE VASCULAR PURCHASE NECESSARY TO TREAT THE TARGETED CALCIFIED OCCLUSION. DURING A CATHETER EXCHANGE ATTEMPT WITHIN THE ILIAC ARTERY, THE 4F CATHETER TIP DETACHED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10370497 ↗
• MalfunctionJul 23, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ILIAC ANGIOPLASTY, AFTER CROSSING THE LONG ILIAC CALCIFIED OCCLUSION, ON REMOVAL OF THE CATHETER THE DISTAL SEGMENT FRACTURED AND WAS RETAINED WITHIN THE PATIENT. THE SEGMENT WAS SUCCESSFULLY RETRIEVED AND NO HARM HAS COME TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317266 ↗
• MalfunctionJul 23, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE BLACK TIP AT THE END OF THE CATHETER GO DETACHED AND LODGED INSIDE ANOTHER CATHETER. THE ACCOUNT STATES THAT THEY WERE ABLE TO RETRIEVE THE TIP. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317243 ↗
• InjuryJul 1, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED LEFT RETROGRADE FEMORAL ARTERY ACCESS WITH THE 4F 90CM CATHETER AND WAS ATTEMPTING TO NEGOTIATE THE PATIENT'S DESCENDING AORTA UNDER FLUOROSCOPY WHEN THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE FOREIGN BODY FROM THE PATIENT'S DESCENDING AORTA WITH A VASCULAR SNARE DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221203 ↗
• InjuryJul 1, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR ANGIOPLASTY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS WITH THE 4F PIG CATHETER. DURING A CATHETER EXCHANGE OVER THE STIFF GUIDE WIRE, THE TIP DETACHED WITHIN THE PATIENT'S COMMON FEMORAL ARTERY BUT REMAINED ON THE WIRE. THE PHYSICIAN NOTED THE PATIENTS EXCESSIVE SCAR TISSUE FROM PREVIOUSLY FEMORAL ARTERY SURGERY. AS THE PHYSICIAN REMOVED THE CATHETER FROM THE VASCULAR ACCESS SITE, THE TIP OF THE CATHETER WAS FOUND PROTRUDING. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED TIP FORM THE PATIENT BY HAND WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221201 ↗
• InjuryJun 18, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTIONAL PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENTS ARTERY. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A STIFF GUIDE WIRE AND 4F CATHETER. DURING A CATHETER EXCHANGE, THE CATHETER TIP DETACHED WITHIN THE PATIENTS COMMON FEMORAL ARTERY AND REMAINED ON THE GUIDE WIRE. IT WAS NOTED THAT THE PATIENT HAD PREVIOUS FEMORAL ARTERY SURGERY, SCAR TISSUE WAS NOTE. THE PHYSICIAN UP SIZED THE SHEATH TO 6F, SO THAT THE GUIDE WIRE AND DETACHED CATHETER TIP COULD BE REMOVED TOGETHER THROUGH THE LARGER SHEATH. THE CATHETER TIP WAS JUST PROTRUDING FROM ACCESS SITE DURING REMOVAL, SO THE PHYSICIAN WAS ABLE TO FINALLY REMOVE THE TIP BY HAND. A NEW CATHETER WAS THEN INTRODUCED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A VASCULAR STENT WAS SUCCESSFULLY PLACED WITHIN THE PATIENTS SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WITH NO ADDITIONAL COMPLICATIONS TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171725 ↗
• InjuryApr 17, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL ENDOVASCULAR AORTIC REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS, THE CATHETER TIP DETACHED WITHIN THE PATIENTS ABDOMINAL AORTA. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED USING A VASCULAR SNARE DEVICE CAUSING NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972580 ↗
• InjuryDec 20, 2019Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PERIPHERAL VASCULAR ANGIOGRAPHY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. DURING CATHETER REMOVAL, OVER THE WIRE THE CATHETER TIP DETACHED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE CATHETER TIP FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9501089 ↗