Impress® 00884450032541Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884450032541), received between Dec 15, 2020 and Aug 9, 2023 — classified as 8 injuries, 3 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.

• InjuryAug 9, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR ANGIOGRAPHY WITH POSSIABLE INTERVENTION [PTA], THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS WITH A GUIDEWIRE AND THE 5F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PROCEDURE WAS DELAYED DUE TO THE POOR HEALTH STATUS OF THE PATIENT LEAVING THE IATROGENIC FOREIGN BODY IN-VIVO. THE PATIENT IS CURRENTLY STABLE. HEALTH STATUS IS IMPROVING. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17487620 ↗
• InjuryAug 9, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CEREBROVASCULAR INTERVENTION PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS WITH A GUIDEWIRE AND THE 5F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS UNDER FLUOROSCOPY, AFTER REACHING THE TARGETED ANATOMICAL SITE WITHIN THE CEREBRAL VASCULATURE SYSTEM THE CATHETER TIP DETACHED. THE PHYSICIAN WAS UNSUCCESSFUL IN EXTERNALIZING THE FOREIGN BODY FROM THE PATIENT AND DECIDED TO LEAVE THE IATROGENIC FOREIGN BODY IN-VIVO. THE PATIENT IS CURRENTLY STABLE. HEALTH STATUS IS IMPROVING. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17487616 ↗
• InjuryAug 7, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTERVENTION, THE CATHETER BROKEN INTO TWO PARTS. WHILE INJECTING CONTRAST, THE PHYSICIAN ROTATED THE CATHETER TO CHANGE THE IMAGE ANGLE AND AT THAT POINT THE TIP DETACHED. A SNARE WAS USED TO REMOVE THE TIP FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476580 ↗
• InjuryJun 6, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE VERTEBRAL CATHETER DISLODGED IN THE DESCENDING AORTA. THE PHYSICIAN ATTEMPTED TO SNARE THE PART OF THE CATHETER OUT, BUT THE FRAGMENT FRACTURED FURTHER. NOT RETRIEVED YET FROM PATIENT'S BODY AS IT BROKE INTO 3 PARTS, THEN TRAVELED AND STUCK AT SMALL BRANCH OF ULNAR, POPLITEAL AND TIBIALIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17076353 ↗
• MalfunctionFeb 21, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CEREBRAL ARTERIOGRAPHY AND CEREBRAL ARTERY EMBOLIZATION PROCEDURE, THE CATHETER WAS FOUND TO HAVE FRAGMENTED AFTER INTRODUCTION. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE FOREIGN BODY. A NEW CATHETER WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415027 ↗
• InjuryFeb 15, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CEREBRAL ANGIOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. MEDICAL INTERVENTION WAS NECESSARY AS THE DEVICE WAS RETRIEVED VIA VASCULAR SNARE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383296 ↗
• InjuryJul 27, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ABDOMINAL AORTOGRAM PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S ABDOMINAL AORTA WITH A GUIDEWIRE AND THE 5F CATHETER. DURING OVER-THE-WIRE CATHETER MANIPULATIONS UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115070 ↗
• InjuryJul 13, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION OF A MID-CEREBRAL ARTERY ANEURYSM PROCEDURE, WHILE USING A 5F DIAGNOSTIC CATHETER, THE TIP OF THE CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND NEGOTIATED THE PATIENT ABDOMINAL AORTA WITH A GUIDEWIRE AND CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE PATIENT'S ABDOMINAL AORTA THE CATHETER TIP DETACHED AND MIGRATED ANTEGRADE, INTO THE COMMON ILIAC ARTERY. DURING ATTEMPTS TO CAPTURE THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE, THE FOREIGN BODY FRAGMENTED INTO TWO PIECES AND MIGRATED FURTHER INTO THE PATIENT'S PERIPHERY. THE PHYSICIAN WANTED TO AVOID FURTHER FRAGMENTATION OF THE FOREIGN BODY, SO THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15009069 ↗
• InjuryDec 16, 2020Fracture; Material Separation; Fracture; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020384 ↗
• MalfunctionDec 15, 2020Fracture; Material Separation; Fracture; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013517 ↗
• MalfunctionDec 15, 2020Fracture; Material Separation; Fracture; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013409 ↗