CARDINAL HEALTH SCVHDODSNCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887488787343), received between Jun 10, 2021 and Jul 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionJul 22, 2021Material Separation; Contamination /Decontamination Problem; Material Separation

  CUSTOMER REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, A PIECE OF LINT WAS FOUND ON THE TOWEL PWTB04-STM FROM THE OPEN HEART PACK SCVHDODSNC. TOWEL USED FOR HOLDING INSTRUMENTS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211253 ↗
• MalfunctionJul 13, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED CLINICAL TEAM OPENED OPEN HEART PACK (SCVHDODSNC) AND REPORTEDLY SAW BLUE LINT FROM BLUE TOWEL (PWTB04-STM) THROUGHOUT PACK COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163918 ↗
• MalfunctionJun 10, 2021Material Frayed; Material Frayed

  UPON OPENING THE OPEN HEART PACK (SCVHDODSNC) FOR OPEN HEART PROCEDURE, THE CLINICIAN NOTICED LINTING FROM THE BLUE TOWELS IN THE PACK AND ON THE TOWEL (PWTB04-STM). THE TOWELS WERE NOT USED ON A PATIENT. NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979906 ↗