CARDINAL HEALTH 28700-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10630140917257), received between May 4, 2021 and Jun 17, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THE OR TOWELS WERE DISINTEGRATING AFTER GETTING WET IN THE STERILE SALINE IN THE STERILE BOWLS, DURING A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION DEVICE PROCEDURE. FUZZY TYPE PIECES WERE COMING OFF. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739144 ↗
• MalfunctionJun 13, 2022Material Separation; Material Separation

  DURING A PULMONARY VEIN ISOLATION CASE, THE NURSE THAT WAS SCRUBBING IN NOTICED RIGHT AWAY WHEN DRYING HER HANDS THAT THE TOWELS HAD EXCESSIVE LINT AND FABRIC PARTICLES. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676133 ↗
• MalfunctionJun 18, 2021Material Separation; Material Separation

  CUSTOMER REPORTED SHREDDING AND EXCESSIVE LINTING OF BLUE OPERATING ROOM TOWELS 28700-006 DURING A CORONARY ANGIOGRAM. TOWELS WERE USED WET TO HOLD WIRE AND CATHETER IN PLACE ON TABLE. ALL LINT WAS REMOVED FROM THE WIRE AND CATHETER WITH SALINE IRRIGATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028871 ↗
• MalfunctionMay 4, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED OR DISPOSABLE TOWELS (28700-006) SHEDDING LINT DURING HEART CATHETERIZATION PROCEDURE. NO INJURY REPORTED AND NO PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773985 ↗