CARDINAL HEALTH SCV5CCCSTIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887488809700), received between Oct 18, 2019 and Nov 26, 2019 — classified as 4 malfunctions.

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

• MalfunctionNov 26, 2019Contamination /Decontamination Problem

  CUSTOMER REPORTED EXCESSIVE LINT ON BLUE OPERATING ROOM (OR) TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9379709 ↗
• MalfunctionNov 26, 2019Device Contamination with Chemical or Other Material

  CUSTOMER REPORTED EXCESSIVE LINT ON THE BLUE OR TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9379705 ↗
• MalfunctionNov 5, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE, NON-X-RAY, COTTON OR TOWEL PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK/ SCV5CCCSTI. THE PROCEDURE PERFORMED WAS A CORONARY ANGIOGRAM WHERE THE TOWELS WERE USED TO DRAPE THE PATIENT AND TO HOLD WIRES ON THE BACK TABLE. LINT WAS FOUND DURING THE PROCEDURE ON A DIAGNOSTIC ANGIOGRAPHY WIRE AND ON GLOVES OF A STAFF MEMBER. THERE WAS NO REPORTED INJURY TO THE PATIENT AND NO PATIENT DEMOGRAPHICS WERE PROVIDED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9281882 ↗
• MalfunctionOct 18, 2019Material Frayed

  THE CUSTOMER REPORTED THAT THE OR TOWELS/ PWTB04-STM FROM THE CARDIAC CATHETER PACK/ SCV5CCCSTI WERE LINTING DURING A CORONARY ANGIOGRAM. THE TOWELS WERE USED TO ABSORB BLOOD AND FLUID ON THE PATIENT'S DRAPE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM. NO PATIENT DEMOGRAPHICS WERE PROVIDED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9211056 ↗