CARDINAL HEALTH SAN11CNSIDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887488973449), received between Mar 29, 2019 and Mar 29, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2019Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING OF WHITE FIBERS FROM THE TOWELS FROM THE CARDIAC CATHETER PACK/ SAN11CNSID. THEY COULD NOT DETERMINE WHETHER IT CAME FROM THE BLUE TOWELS PWT304-STM OR THE WHITE TOWELS A8520BN. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS REPORTED. THE MDR WILL BE FILED FOR MALFUNCTION AND POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466610 ↗
• MalfunctionMar 29, 2019Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING OF WHITE FIBERS FROM THE TOWELS FROM THE CARDIAC CATHETER PACK/ SAN11CNSID. THEY COULD NOT DETERMINE WHETHER IT CAME FROM THE BLUE TOWELS PWT304-STM OR THE WHITE TOWELS A8520BN. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS REPORTED. THE MDR WILL BE FILED FOR MALFUNCTION AND POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466579 ↗
• MalfunctionMar 29, 2019Material Frayed

  THE CUSTOMER REPORTED EXCESSIVE LINTING OF WHITE FIBERS FROM THE TOWELS FROM THE CARDIAC CATHETER PACK/ SAN11CNSID. THEY COULD NOT DETERMINE WHETHER IT CAME FROM THE BLUE TOWELS PWT304-STM OR THE WHITE TOWELS A8520BN. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS REPORTED. THE MDR WILL BE FILED FOR MALFUNCTION AND POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466554 ↗
• MalfunctionMar 29, 2019Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING OF WHITE FIBERS FROM THE TOWELS FROM THE CARDIAC CATHETER PACK/ SAN11CNSID. THEY COULD NOT DETERMINE WHETHER IT CAME FROM THE BLUE TOWELS PWT304-STM OR THE WHITE TOWELS A8520BN. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS REPORTED. THE MDR WILL BE FILED FOR MALFUNCTION AND POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466538 ↗
• MalfunctionMar 29, 2019Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE LINTING OF WHITE FIBERS FROM THE TOWELS FROM THE CARDIAC CATHETER PACK/ SAN11CNSID. THEY COULD NOT DETERMINE WHETHER IT CAME FROM THE BLUE TOWELS PWT304-STM OR THE WHITE TOWELS A8520BN. THE PROCEDURE PERFORMED WAS CARDIAC CATHETERIZATION WITH ANGIOPLASTY. THERE WAS NO REPORT OF INJURY. NO PATIENT DEMOGRAPHICS OR CLINICAL DATA WAS REPORTED. THE MDR WILL BE FILED FOR MALFUNCTION AND POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466287 ↗