CARDINAL HEALTH SAN37CPBSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439054286), received between Sep 13, 2019 and Oct 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2019Contamination /Decontamination Problem

  BASED ON INFORMATION FROM CUSTOMER, THEY ARE STILL REPORTEDLY EXPERIENCING LINTING OF TOWELS IN THEIR CUSTOM PACK. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9233321 ↗
• MalfunctionOct 3, 2019Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE CATHETERIZATION PACK/ SAN37CPBSD.. THE PROCEDURE PERFORMED WAS A CARDIAC CATHETERIZATION WHERE THE TOWELS WERE USED TO DRAPE THE LEGS OF THE PATIENT. LINT WAS FOUND DURING THE PROCEDURE ON THE GUIDEWIRES AND TOWELS. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED. THE EVENT DATE WAS UNKNOWN BY OUR CUSTOMER (1-JAN-1980 IS A DEFAULT UNKNOWN DATE) . MDR BEING FILED FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153505 ↗
• MalfunctionSep 13, 2019Contamination

  THE CUSTOMER REPORTED LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE CATHETERIZATION PACK/ SAN37CPBSD. THE PROCEDURE PERFORMED WAS A CARDIAC CATHETERIZATION WHERE THE TOWELS WERE USED TO DRAPE THE LEGS OF THE PATIENT. LINT WAS FOUND DURING THE PROCEDURE ON THE GUIDEWIRES AND TOWELS. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO PATIENT DEMOGRAPHICS PROVIDED. POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9048332 ↗