Impress® 00884450009215Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450009215), received between Jan 7, 2022 and Feb 27, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING A RENAL ANGIOGRAPHY AFTER SUCCESSFUL CANNULATION OF THE RENAL OSTIUM THEY WERE MANIPULATING/TORQUING AND POSITIONING THE CATHETER FOR A CONTRAST INJECTION. DURING THE CONTRAST HAND INJECTION, THE CATHETER TIP STARTED TO DETACH. THE ACCOUNT WAS ABLE TO REWIRE THE CATHETER WITH A GUIDEWIRE SO THAT THE GUIDEWIRE AND CATHETER TIP WERE SUCCESSFULLY REMOVED FROM THIS PATIENT AS A UNIT. AFTER CATHETER REMOVAL EX-VIVO, THEY CONTINUED TO MANIPULATE THE CATHETER AGAIN CHECKING FOR CATHETER FLEXIBILITY WHEN THE TIP FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793948 ↗
• InjuryFeb 27, 2024Fracture; Material Fragmentation; Detachment of Device or Device Component; Fracture; Material Fragmentation; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING A TIPS PROCEDURE VIA RADIAL ACCESS THROUGH THE CELIAC ARTERY, THE CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL RADIAL ACCESS AND DURING CATHETER MANIPULATIONS, THE TIP FRAGMENTED WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO SNARE THE FRAGMENTS FROM THE PATIENT WITH A VASCULAR SNARE DEVICE, BUT THE TARGETED FOREIGN BODY FRAGMENTED AGAIN AFTER CAPTURE WITHIN THE PATIENT'S VASCULATURE SYSTEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18793947 ↗
• InjurySep 13, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ILIAC VENOGRAPHY, THE TIP OF THE CATHETER CRACKED INTO PIECES DURING THE PASSAGE TO THE COMMON ILIAC ARTERY. SOME OF THE PIECES WERE REMAIN WITHIN THE PATIENT BODY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17736117 ↗
• InjuryAug 17, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEUROIMAGING PROCEDURE, FOLLOWING AN ILIAC ARTERY ANGIOGRAPHY, THE TIP OF THE CATHETER CRACKED AND DETACHED. SEVERAL ATTEMPTS WERE MADE TO SUCCESSFULLY RETRIEVE THE DETACHED PIECE. DURING THE ATTEMPTS, THE PIECE FRACTURED INTO TWO SEPARATE PIECES. ONE OF THE FRACTURED PIECES WAS SUCCESSFULLY REMOVED. THE OTHER REMAINING PIECE IS STILL WITHIN THE PATIENT'S LOWER LIMB ARTERY AND WILL REQUIRE AN ADDITIONAL PROCEDURE FOR REMOVAL. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15246763 ↗
• InjuryFeb 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE OF THE CATHETER IN THE RBI, THE CATHETER BROKE IN THE VESSEL AND COULD NOT BE REMOVED. THE REMNANTS OF THE DEVICE WERE LEFT WITHIN A STENT GRAFT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13536823 ↗
• InjuryJan 7, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE CATHETER TIP DETACHED WITHIN THE VESSEL OF THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT THROUGH OPEN SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197882 ↗