Impress® 00884450035832Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884450035832), received between Jan 26, 2021 and May 11, 2023 — classified as 11 injuries.

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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BILATERAL UTERINE ARTY CHEMOEMBOLIZATION PROCEDURE THE CATHETER TIP DETACHED. AN ADDITIONAL CATHETER WAS USED WITH A SNARE DEVICE TO ATTEMPT TO RETRIEVE THE FOREIGN BODY. THE NEW CATHETER TIP DETACHED AS WELL. BOTH FOREIGN BODIES WERE RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911291 ↗
• InjuryMay 11, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BILATERAL UTERINE ARTY CHEMOEMBOLIZATION PROCEDURE THE CATHETER TIP DETACHED. AN ADDITIONAL CATHETER WAS USED WITH A SNARE DEVICE TO ATTEMPT TO RETRIEVE THE FOREIGN BODY. THE NEW CATHETER TIP DETACHED AS WELL. BOTH FOREIGN BODIES WERE RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911278 ↗
• InjurySep 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ENDOVASCULAR AORTIC REPAIR [EVAR] PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY NAVIGATED THE ILIO-FEMORAL CONDUIT AND ACQUIRED BILATERAL FEMORAL ARTERY ACCESS. AS THE PHYSICIAN WAS TRYING TO REMOVE THE CATHETER FROM THE PATIENT, OVER A GUIDEWIRE, UNDER FLUOROSCOPY THE CATHETER TIP DETACHED. THE PHYSICIAN ATTEMPTED TO USE A VASCULAR SNARE DEVICE TO EXTERNALIZED THE FOREIGN BODY, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE FOREIGN BODY FRAGMENTED WITH EACH ATTEMPT INTO SMALLER FOREIGN BODIES. A PIECE OF THE CATHETER MIGRATED INTO THE PATIENT INTERNAL ILIAC ARTERY. THE CLINICIAN EMBOLIZED THE FOREIGN BODY WITHIN VASCULAR COILS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15335731 ↗
• InjuryJun 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A CEREBRAL ANGIOGRAPHY PROCEDURE, THE 5F CATHETER TIP DETACHED WITHIN THE PATIENT, THE PHYSICIAN ACQUIRED RETROGRADE ARTERIAL ACCESS, AND DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861045 ↗
• InjuryJun 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE THE 5F CATHETER TIP DETACHED WITHIN AN ILIAC ANEURYSM. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS, AND DURING CATHETER MANIPULATIONS OVER A GUIDEWIRE UNDER FLUOROSCOPY, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY EXTERNALIZE THE FOREIGN BODY FROM THE PATIENT LIBERATING THE VESSEL. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860899 ↗
• InjuryApr 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, WHILE REMOVING THE DEVICE FROM THE PATIENT, THE TIP CRACKED AND SEPARATED FROM THE REST OF THE DEVICE WITHIN THE VESSEL. THE SEPARATED PIECE WAS SUCCESSFULLY RETRIEVED USING A CAPTURE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972605 ↗
• InjuryJan 18, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A STANDARD ANGIO PROCEDURE, THE TIP OF THE CATHETER SHEARED OFF IN AN ATTEMPT TO SWAP IT OUT. THE TIP WAS SUCCESSFULLY RETRIEVED USING A SNARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13286098 ↗
• InjuryJan 5, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE TIP OF THE CATHETER CRACKED INTO TWO PIECES WITHIN THE PATIENT'S BODY. ONE PIECE WAS REMOVED; HOWEVER, THE OTHER SMALLER PIECE REMAINED IN THE PATIENT'S VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13170171 ↗
• InjuryDec 20, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A UTERINE ARTERY EMBOLIZATION [UAE] PROCEDURE THE CATHETER TIP DETACHED WITHIN THE PATIENT'S ARTERY. THE PHYSICIAN ACQUIRED VASCULAR ACCESS VIA SELDINGER TECHNIQUE TO INSERT THE 5F SHEATH USING A PIG TAIL CATHETER TO ENTER THE LOWER PART OF THE ABDOMINAL AORTA FOR FLUOROSCOPIC IMAGING. THE BILATERAL UTERINE ARTERIES WERE OBVIOUSLY THICKENED AND TORTUOUS. THE 5F ANGIOGRAPHY CATHETER WAS INSERTED THROUGH THE SHEATH, AND AN ULTRA-SMOOTH GUIDE WIRE WAS USED TO PERFORM THE ANGIOGRAPHY OF THE LEFT INTERNAL ILIAC ARTERY. IT WAS FOUND THAT THE ANTERIOR SEGMENT OF THE ANGIOGRAPHY CATHETER HAD KINKED AND BENT. DURING AN ATTEMPT TO GENTLY WITHDRAW THE ANGIOGRAPHY CATHETER IT COMPLETELY DETACHED WITHIN THE PATIENT. AFTER INSERTING A VASCULAR SNARE DEVICE, THE BROKEN ANGIOGRAPHY CATHETER WAS SUCCESSFULLY CAPTURED. WHEN TRYING TO REMOVE THE ANGIOGRAPHY CATHETER, AGAIN THE FOREIGN BODY RUPTURED. FLUOROSCOPIC INSPECTION DEMONSTRATED THAT A 10MM FOREIGN BODY REMAINS WITHIN THE TERMINAL BRANCH OF THE LEFT DEEP FEMORAL ARTERY. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE FOREIGN BODY, BUT THEY WERE UNSUCCESSFUL. GENERAL SURGERY WAS CONSULTED FOR EMERGENT SURGICAL EXTRACT

  Patient problems: Foreign Body In Patient

  MAUDE report 13050105 ↗
• InjuryNov 16, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE CATHETER TIP DETACHED FROM THE REST OF THE UNIT. THE FRAGMENT WAS SUCCESSFULLY REMOVED USING A ONE SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824588 ↗
• InjuryJan 26, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROSTATE ARTERY EMBOLIZATION (PAE) PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY AND OVER-THE-WIRE, THE CATHETER TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233279 ↗