CARDINAL HEALTH SANOCCCORCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488743615), received between Dec 6, 2019 and Dec 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY, COTTON OR TOWEL PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK/ SANOCCCORC. THE PROCEDURE PERFORMED WAS AN ANGIOPLASTY. UPON EXITING THE CORONARY ARTERY, LINT WAS FOUND TO BE STICKING TO THE BALLOON. THE LINT WAS REMOVED FROM THE BALLOON AT THAT TIME. NO INJURY WAS REPORTED. THERE WAS NO DELAY IN PATIENT CARE AS THE TOWELS WERE THEN REMOVED FROM THE FIELD AND A SEPARATE PACK OF OR TOWELS WERE DROPPED ONTO THE FIELD FOR USE. THE EVENT DATE OF THE INCIDENT WAS UNKNOWN BY THE CUSTOMER. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9433164 ↗
• MalfunctionDec 6, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY, COTTON OR TOWEL PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK/ SANOCCCORC. THE EVENT DATE OF THE INCIDENT WAS UNKNOWN BY THE CUSTOMER. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN. ALTHOUGH NO INJURY WAS REPORTED, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9432900 ↗