CARDINAL HEALTH CHIP99OH7DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439008050), received between Aug 4, 2020 and Oct 6, 2020 — classified as 3 malfunctions.

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

• MalfunctionOct 6, 2020Defective Component

  CUSTOMER REPORTED EXCESSIVE LINTING OF THE BLUE COTTON OR TOWELS PWTB04-STM FROM THE OPEN HEART PACK CHIP99OH7D DURING A CORONARY ARTERY BYPASS GRAFT, CABG. LINT WAS FOUND ON ALL SCRUBBED PERSON¿S GLOVED HANDS, ON THE INSTRUMENTS BEING USED, AND FLOATING IN THE SALINE IRRIGATION AND SLUSH MACHINE. ATTEMPTS WERE MADE TO KEEP INSTRUMENTS AND GLOVED HANDS CLEAN. TOWELS WERE USED TO SQUARE OFF THE CHEST WOUND DURING THE PROCEDURE AND MOISTENED TOWELS WERE ALSO USED TO KEEP INSTRUMENTS CLEAN AND FREE OF DEBRIS DURING THE PROCEDURE. THERE WAS NO DELAY OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10638739 ↗
• MalfunctionSep 1, 2020Material Fragmentation

  CUSTOMER REPORTED THAT HIGH LINT LEVELS FROM THE OPERATING ROOM TOWELS PWTB04-STM IN THE OPEN HEAR BASIC PACK CHIP99OH7D WERE FOUND ON STAFF¿S HANDS AND INSTRUMENTS DURING A CORONARY ARTERY BYPASS GRAFT, CABG, PROCEDURE. THERE WAS NO PATIENT INJURY. REPORT BEING FILED FOR RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10480243 ↗
• MalfunctionAug 4, 2020Material Fragmentation

  CUSTOMER REPORTED MORE LINT THEN NORMAL FROM BLUE TOWELS IN THE OPEN HEART BASIC PACK DURING AORTIC VALVE REPLACEMENT PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10364710 ↗