CARDINAL HEALTH SAN7HITEMIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197106706541), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionJul 16, 2025Delivered as Unsterile Product

  FROM STAFF: WHEN THE TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] TEAM OPENED THEIR STERILE PACK TO SET UP THE OR ROOM, IT WAS DISCOVERED THAT THE DRAPE IN PACK WAS NOT STERILE. IT WAS COVERED IN BLACK DOTS. THE TEAM DISCARDED THE PACK, SAVED THE DRAPE AND LABEL FOR REPORTING AND STARTING THEIR ROOM OPENING OVER FROM THE BEGINNING. NO UNSTERILE EQUIPMENT WAS USED ON THE PATIENT. THIS MANAGER REPORTED THE INCIDENT TO CARDINAL HEALTH AND SUPPLY CHAIN HERE AT THE HOSPITAL. MANUFACTURER RESPONSE FOR ANGIOGRAPHY/ANGIOPLASTY KIT, CARDINAL HEALTH (PER SITE REPORTER). SALES REP, [REDACTED] (SEE CONTACT INFORMATION BELOW), WILL GET A QUALITY REPORT FILED AND WILL ISSUE A CREDIT FOR THE PACK. HER RESPONSE "I REALLY APOLOGIZE FOR THIS INCONVENIENCE AND PLEASE KEEP ME POSTED IF YOU RUN INTO ANY MORE ISSUES. " [REDACTED] . SALES REPRESENTATIVE- BOSTON SOUTH. ACUTE OPERATING ROOM SPECIALTY PRODUCTS. MOBILE: [REDACTED].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519165 ↗