CARDINAL HEALTH SAN11AN10HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439111248), received between Mar 12, 2019 and Mar 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2019Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT THE OPERATING ROOM TOWELS PWTB04-STM FROM THE NEURO EMBOLISM PACK/SAN11AN10H HAVE LINT AND IT IS UNSAFE TO USE FOR THE PATIENT UNDERGOING SURGERY. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418419 ↗
• MalfunctionMar 12, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT DURING A CLOT RETRIEVAL ON A STROKE, LINT FROM THE BLUE OR TOWELS PWTB04-STM FROM THE NEURO EMBOLISM PACK/SAN11AN10H WAS FOUND ON A STENT. THE LINT DID NOT REACH THE PATIENT, THERE WAS NO DELAY AND NO INJURY. NO PATIENT DEMOGRAPHICS OR FURTHER DATA WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411562 ↗