CARDINAL HEALTH SCV15OHRMHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488901657), received between May 24, 2019 and Jun 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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.

• MalfunctionJun 20, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE WHITE ABSORBENT TOWEL (B)(4) FROM THE LEFT HEART PACK, (B)(4) DEPOSITED LOOSE FIBERS INTO THE SALINE FLUSH BOWL AFTER BEING DIPPED IN. NO PATIENT DEMOGRAPHICS WERE PROVIDED NOR WAS ANY INJURY REPORTED. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. THE MDR IS BEING FILED FOR POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716693 ↗
• MalfunctionMay 24, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE WHITE ABSORBENT TOWEL A8520BN FROM THE LEFT HEART PACK, SCV15OHRMH DEPOSITED LOOSE FIBERS INTO THE SALINE FLUSH BOWL AFTER BEING DIPPED IN. NO PATIENT DEMOGRAPHICS WERE PROVIDED NOR WAS ANY INJURY REPORTED. THE MDR IS BEING FILED FOR POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640910 ↗