Impress® 00884450035955Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450035955), received between May 6, 2021 and Aug 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTERVENTION, THE CATHETER BROKEN INTO TWO PARTS. THE CATHETER TIP DETACHED WITHIN THE PATIENT'S BODY. DUE TO POOR PATIENT HEALTH STATUS, THE PHYSICIAN STOPPED THE PROCEDURE. PATIENT STATUS IS STABLE WITH CONTINUING CONDITION AND NO REPORT OF ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17475744 ↗
• InjuryApr 25, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] PROCEDURE WITHIN THE PATIENT'S PERIPHERY, A CATHETER TIP DETACHED. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE POPLITEAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S CONTRALATERAL LEFT ILIO-FEMORAL CONDUIT WITH AN INTERVENTIONAL GUIDEWIRE AND A 5F CATHETER. DURING CATHETER MANIPULATIONS UNDER FLUOROSCOPY THE CATHETER TIP DETACHED BUT REMAINED ON THE GUIDEWIRE. THE DETACHED CATHETER TIP WAS REMOVED ALONG WITH THE GUIDEWIRE. NO ADDITIONAL MEDICAL INTERVENTION WAS DEEMED NECESSARY. A NEW DEVICE WAS USED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811832 ↗
• InjuryMay 6, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING AN EMBOLIZATION/SPINAL ANGIOGRAM PROCEDURE THAT ORIGINATED ON (B)(6) 2021, FOR A SPINAL CORD ARTERIOVENOUS MALFORMATION (AVM), A CATHETER TIP DETACHED IN SEVERAL PIECES WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY ACQUIRED RIGHT RETROGRADE FEMORAL ARTERY ACCESS WITH A 6F SHEATH AND HAD SUCCESSFULLY NEGOTIATED THE PATIENT ILIAC BIFURCATION TO SUCCESSFULLY CANNULATE THE OSTIUM OF A INTERCOSTAL ARTERY TO OPACIFY SPINAL AVM VESSELS UNDER FLUOROSCOPY WITH A 5F CB2 CATHETER. DURING CATHETER MANIPULATIONS WITHIN THE INTERCOSTAL ARTERY, THE CATHETER DETACHED INTO THREE PIECES IN-VIVO AND MIGRATED TOWARD THE PATIENT'S PERIPHERY. SECONDARY BILATERAL VASCULAR ACCESS WAS ACQUIRED VIA THE LEFT RETROGRADE FEMORAL ARTERY WITH A 9F SHEATH IN AN ATTEMPT TO RETRIEVE THE FOREIGN BODIES LOCATED WITHIN AN INTERCOSTAL ARTERY WHEN THE FOREIGN BODY ONCE AGAIN DETACHED WITHIN THE PATIENT. THE PHYSICIAN STOPPED THE PROCEDURE AND STARTED 3000 U OF HEPARIN. ULTRASONOGRAPHY IMAGING WAS ORDERED FOR THE LOWER EXTREMITIES INCLUDING THE RENAL ARTERIES. ADDITIONAL OBSERVATION TIME WAS EXTENDED 48 HOURS FOR THE LOWER EXTREMITIES. THE CATHETER WAS THEN REMOVED FROM THE PATIENT AND DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787859 ↗