CARDINAL HEALTH SAN22CVWRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887488869803), received between Mar 15, 2019 and Feb 5, 2020 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2020Contamination

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE CARDIOVASCULAR PACK SAN22CVWRG. THE PROCEDURE THAT WAS PERFORMED WAS A CARDIAC CATHETERIZATION. 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 9672718 ↗
• MalfunctionJan 28, 2020Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY COTTON TOWELS PWTB04-STM FROM THE CARDIOVASCULAR PACK SAN22CVWRG. THE PROCEDURE BEING PERFORMED WAS A CARDIAC CATHETERIZATION. 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 9639303 ↗
• InjuryMar 15, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE BLUE, NON- X-RAY TOWELS 101625 FROM THE CENTRAL VENOUS LINE PACK/ SAN22CVWRG WERE LINTING AND FIBERS WERE FOUND ON THE STAFF¿S GLOVES AND IN A BOWL OF SALINE. IT WAS REPORTED THAT A PATIENT HAD A STROKE. NO PATIENT DEMOGRAPHICS OR ANY CLINICAL DATA TO LINK THE EVENTS WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 8426201 ↗
• InjuryMar 15, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE BLUE, NON- X-RAY TOWELS 101625 FROM THE CENTRAL VENOUS LINE PACK/ SAN22CVWRG WERE LINTING AND FIBERS WERE FOUND ON THE STAFF¿S GLOVES AND IN A BOWL OF SALINE. IT WAS REPORTED THAT A PATIENT HAD A STROKE. NO PATIENT DEMOGRAPHICS OR ANY CLINICAL DATA TO LINK THE EVENTS WAS PROVIDED.

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 8426164 ↗