SureCross 00884450187753Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450187753), received between Jun 24, 2020 and Jun 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2020Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR INTERVENTION PROCEDURE THE MARKER BAND ON THE SUPPORT CATHETER DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL VASCULAR ACCESS AND DURING SUPPORT CATHETER MANIPULATIONS OVER THE WIRE WITHIN THE PATIENTS LEFT LOWER LIMB WHEN CROSSING THE LESION, THE RADIOPAQUE MARKER BAND DETACHED BUT REMAINED ON THE GUIDEWIRE. THE MARKER BAND WAS SUCCESSFULLY RETRIEVED WITH THE SUPPORT OF AN ADDITIONAL GUIDE WIRE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10189958 ↗