CARDINAL HEALTH SAN29MACCURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488737195), received between Apr 4, 2019 and Apr 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2019Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF WHITE FIBERS ON THE OR TOWELS 01625 FROM THE FEMORAL ANGIOGRAPHY TRANSJUGULAR PACK/ SAN29MACCU. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC CEREBRAL ANGIOGRAM WHERE THE TOWELS WERE USED ON TOP OF THE DRAPE TO ABSORB PROCEDURE FLUIDS. THERE WAS NO PATIENT INJURY OR DELAY IN PROCEDURE. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484784 ↗
• MalfunctionApr 4, 2019Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF WHITE FIBERS ON THE OPERATING ROOM TOWELS 01625 FROM THE FEMORAL ANGIOGRAPHY TRANSJUGULAR PACK/ SAN29MACCU. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC CEREBRAL ANGIOGRAM WHERE THE TOWELS WERE USED ON TOP OF THE DRAPE TO ABSORB PROCEDURE FLUIDS. THERE WAS NO PATIENT INJURY OR DELAY IN PROCEDURE. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484755 ↗