CARDINAL HEALTH PVVMHT231Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439831795), received between Jul 16, 2020 and Jul 22, 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 16, 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, 2020Material Fragmentation

  SCRUB NURSE REPORTED LINTING FROM BLUE TOWELS BEFORE OPEN HEART SURGERY PROCEDURE. THE LINT WAS FOUND WHEN THE SCRUB NURSE TOOK TWO FROM THE PACK TO DRY HER HANDS AND ARMS. THERE WAS NO INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311816 ↗
• MalfunctionJul 22, 2020Material Fragmentation

  SCRUB NURSE REPORTED LINTING FROM BLUE TOWELS BEFORE OPEN HEART SURGERY PROCEDURE. THE LINT WAS FOUND WHEN THE SCRUB NURSE WAS DRYING HER HANDS FOR THE FIRST PATIENT. THERE WAS NO INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311805 ↗
• MalfunctionJul 16, 2020Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING DURING RIGHT THORACOTOMY MITRAL VALVE REPLACEMENT PROCEDURE. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286637 ↗