Impress® 00884450032565Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884450032565), received between Nov 25, 2019 and Feb 21, 2023 — classified as 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR EXAMINATION ON A PATIENT, THE OPERATOR PLACED THE CATHETER AT THE LEVEL OF THE AORTA WITH A CURVED 0.035 X 150CM GUIDE AND IMMEDIATELY AFTER THAT THE END OF THE CATHETER MIGRATED DURING THE REMOVAL OF THE GUIDE. THE END GOT STUCK IN THE ABDOMINAL AORTA AND WHEN TRYING TO RETRIEVE THE TIP WITH A LASSO THE END OF THE CATHETER WAS CUT INTO SEVERAL PIECES. A RETRIEVAL BASKET WAS USED TO RETRIEVE THE DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415039 ↗
• MalfunctionNov 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING REVASCULARIZATION OF THE LOWER LIMB, THE TIP OF THE CATHETER BROKE WHILE INSIDE THE PATIENT'S ARTERY. THE ENTIRE SYSTEM WAS REMOVED AS THE DETACHED PORTION REMAINED ON THE GUIDWIRE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756751 ↗
• InjurySep 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM [PTA] STENT INSERTION PROCEDURE, THE CATHETER TIP DETACHED 20MM BELOW THE PRIMARY ANGLE OF THE CURVATURE WITHIN THE PATIENT. A VASCULAR SNARE DEVICE WAS USED TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380252 ↗
• InjurySep 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL BILIARY STENT DEPLOYMENT PROCEDURE, THE GUIDE CATHETER TIP DETACHED WITHIN THE PATIENT. TWO INTERVENTIONAL RADIOLOGISTS TRIED UNSUCCESSFULLY TO RETRIEVE THE BROKEN PIECES FROM WITHIN THE PATIENT USING VASCULAR SNARE DEVICES. ALL RETRIEVAL ATTEMPTS FOR THE FOREIGN BODIES WERE EVENTUALLY ABANDONED. THE CLINICAL TEAM SUGGESTED A PATIENT TRANSFER TO ANOTHER HEALTHCARE FACILITY WITH THE ABILITY TO ATTEMPT ADDITIONAL FOREIGN BODY RETRIEVAL ATTEMPTS WITH VARIOUS RETRIEVAL DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15335754 ↗
• InjuryAug 31, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PHLEBOGRAPHY OF THE SPLENIC VEIN, THE CATHETER FRACTURED DISPLACING THE RADIOPAQUE DISTAL SEGMENT. IT WAS NECESSARY TO USE A CAPTURE LOOP TO REMOVE THE CATHETER FRAGMENT WITHOUT FURTHER COMPLICATIONS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331423 ↗
• InjuryAug 31, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT BALLOON VENOPLASTY, THE CATHETER BROKE DURING MANIPULATION AT THE LEFT BRACHIOCEPHALIC VEIN-SVC JUNCTION. THE FRACTURED PORTION OF THE CATHETER WAS REMOVED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331401 ↗
• InjuryAug 24, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR INTERVENTION PROCEDURE, THE CATHETER FRACTURED WHILE INSIDE THE PATIENT. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283179 ↗
• InjuryJul 8, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT WITHOUT ANY ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139986 ↗
• InjuryJul 8, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT WITHOUT ANY ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139985 ↗
• MalfunctionJul 8, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE TIP OF THE CATHETER BROKE AND ALMOST DETACHED WITHIN THE PATIENT DURING THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139983 ↗
• InjuryJul 8, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT WITHOUT ANY ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139982 ↗
• InjuryMay 12, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE THE CATHETER TIP OF A 5F RBI CATHETER DETACHED WITHIN THE PATIENT'S ANATOMY. A VASCULAR SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FORM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813236 ↗
• MalfunctionMay 12, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE CATHETER TIP DETACHED OUTSIDE THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS, AND THE CATHETER WAS INTRODUCED OVER A STIFF GUIDEWIRE, THE LESION WAS CROSSED, AND CONTRAST WAS INJECTED TO COLLECT SELECTIVE ANGIOGRAMS. THE CATHETER WAS REMOVED FROM THE PATIENT AND PLACED BACK ON THE STERILE FIELD. AT A LATER POINT WITHIN THE PROCEDURE, THE CLINICIAN DECIDED TO USE THE 5F KA2 CATHETER AGAIN. WHEN AN ATTEMPT WAS MADE TO RELOAD THE CATHETER OVER THE BACK END OF THE GUIDEWIRE, THE TIP DETACHED AND WAS DANGLING FROM THE CATHETER SHAFT. A NEW CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813233 ↗
• MalfunctionNov 24, 2020Break; Material Rupture; Break; Material Rupture

  THE ACCOUNT ALLEGES THAT DURING AN ARTERIOGRAM PROCEDURE, THE CATHETER TIP PARTIALLY DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS. UNDER FLUOROSCOPY IT WAS NOTED THAT CONTRAST WAS COMING OUT OF THE SHAFT WHERE THE RUBBER TIP IS FUSED. THE PARTIALLY DETACHED CATHETER TIP WAS SUCCESSFULLY REMOVED TOGETHER WITH THE GUIDEWIRE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896479 ↗
• MalfunctionNov 24, 2020Break; Material Rupture; Break; Material Rupture

  THE ACCOUNT ALLEGES THAT DURING AN ARTERIOGRAM PROCEDURE, THE CATHETER TIP PARTIALLY DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS. UNDER FLUOROSCOPY IT WAS NOTED THAT CONTRAST WAS COMING OUT OF THE SHAFT WHERE THE RUBBER TIP IS FUSED. THE PARTIALLY DETACHED CATHETER TIP WAS SUCCESSFULLY REMOVED TOGETHER WITH THE GUIDEWIRE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896379 ↗
• MalfunctionApr 9, 2020Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL THROMBECTOMY PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9945998 ↗
• InjuryNov 25, 2019Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY PROCEDURE ACCESS WAS GAINED INTO THE KIDNEY THEN THE CATHETER WAS USED TO GUIDE THE GUIDE WIRE WHEN THE CATHETER TIP DETACHED IN THE KIDNEY. INTERVENTION WAS REQUIRED TO REMOVE CATHETER TIP FROM KIDNEY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9371078 ↗
• InjuryNov 25, 2019Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY PROCEDURE ACCESS WAS GAINED INTO THE KIDNEY THEN THE CATHETER WAS USED TO GUIDE THE GUIDE WIRE WHEN THE CATHETER TIP DETACHED IN THE KIDNEY. INTERVENTION WAS REQUIRED TO REMOVE CATHETER TIP FROM KIDNEY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9371068 ↗
• MalfunctionNov 25, 2019Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY PROCEDURE ACCESS WAS GAINED INTO THE KIDNEY THEN THE CATHETER WAS USED TO GUIDE THE GUIDE WIRE WHEN THE CATHETER TIP DETACHED IN THE KIDNEY. INTERVENTION WAS REQUIRED TO REMOVE CATHETER TIP FROM KIDNEY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9371050 ↗