CARDINAL HEALTH SAN22ANWRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887488564388), received between Jan 17, 2020 and Jan 30, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2020Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC. THE PROCEDURE BEING PERFORMED WAS A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. THERE WAS NO APPARENT INJURY OR NEGATIVE PATIENT OUTCOME DURING THE PROCEDURE, ONLY A DELAY TO CHANGE GLOVES, REMOVE TOWELS AND EMPTY FLUID CONTAINERS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9649288 ↗
• MalfunctionJan 28, 2020Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC. THE PROCEDURE BEING PERFORMED WAS A CEREBRAL ANGIOGRAM WITH THROMBECTOMY. THERE WAS NO APPARENT INJURY OR NEGATIVE PATIENT OUTCOME DURING THE PROCEDURE, ONLY A DELAY TO CHANGE GLOVES, REMOVE TOWELS AND EMPTY FLUID CONTAINERS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9639355 ↗
• MalfunctionJan 27, 2020Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC. THE PROCEDURE BEING PERFORMED WAS A CEREBRAL ANGIOGRAPHY WITH THROMBECTOMY. THERE WAS NO APPARENT INJURY OR NEGATIVE PATIENT OUTCOME DURING THE PROCEDURE, ONLY A DELAY TO CHANGE GLOVES, REMOVE TOWELS AND EMPTY FLUID CONTAINERS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9634772 ↗
• MalfunctionJan 27, 2020Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC DURING A CEREBRAL ANGIOGRAPHY AND ANEURYSM ASSESSMENT. THERE WAS NO APPARENT INJURY OR NEGATIVE PATIENT OUTCOME DURING THE PROCEDURE, ONLY A DELAY TO CHANGE GLOVES, REMOVE TOWELS AND EMPTY FLUID CONTAINERS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633751 ↗
• MalfunctionJan 27, 2020Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC DURING A PORT INSERTION. THERE WAS NO APPARENT INJURY OR NEGATIVE PATIENT OUTCOME DURING THE PROCEDURE, ONLY A DELAY TO CHANGE GLOVES, REMOVE TOWELS AND EMPTY FLUID CONTAINERS. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633539 ↗
• MalfunctionJan 17, 2020Contamination

  THE CUSTOMER REPORTED LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN22ANWRC DURING A CARDIAC CATHETER PROCEDURE. LINT WAS FOUND ON GLOVES, TOWELS AND IN FLUID CONTAINERS. THE TOWELS WERE USED OVER TOP OF DRAPE TO ABSORB EXCESS FLUID. NO APPARENT NEGATIVE PATIENT OUTCOMES OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER GLOVES WERE CHANGED, LINTING TOWELS REMOVED AND FLUID CONTAINERS WERE EMPTIED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604635 ↗