CARDINAL HEALTH SAN12CCROJRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885425518159), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unraveled Material” (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 18, 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.

• InjuryOct 17, 2018Unraveled Material

  THE CUSTOMER STATED THAT THE BLUE OPERATING ROOM TOWELS, COMPONENT PWTB03-STMA FROM CATALOG SAN12CCROJ/CATH LAB TRAY, WERE UNRAVELING CAUSING FREE FLOATING STRINGS. THE STRINGS REPORTEDLY CAUSED A THROMBUS IN THE PATIENT¿S RIGHT CORONARY ARTERY WHICH WAS ABLE TO BE REMOVED BY A PRONTO THROMBUS EXTRACTION CATHETER. UPON THE FOLLOW UP VISIT WITH THE PATIENT, RESIDUAL THROMBUS WAS FOUND AND REQUIRED COVERED STENTS TO BE PLACED TO PREVENT FURTHER THROMBUS. THE PATIENT IS NOW STABLE BUT WITH THE ADDITIONAL STENTS, THE PATIENT WILL REQUIRE LONG TERM ANTI-COAGULATION. THE EVENT DATE IS UNKNOWN.

  Patient problems: Thrombus

  MAUDE report 7973175 ↗