CARDINAL HEALTH SAN43HCJMDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888439623567), received between Feb 16, 2021 and Feb 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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.

• MalfunctionFeb 16, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED BLUE TOWELS (PWTB04-STM) IN KIT (SAN43HCJMD) SHEDDING A LOT OF LINT DURING PERIPHERAL INTERVENTIONAL PROCEDURE. WHEN THE TOWELS STAY WET IN THE BOWL, BLUE LINT WAS FOUND AT THE BOTTOM OF THE BOWL AND REPORTEDLY IT CAUSES THE WIRES TO GET CAUGHT UP IN THE BLUE TOWELS. THE TOWELS WERE USED TO HOLD THE WIRES DOWN ON THE TABLE AND FOR EXCESS FLOW OF BLOOD FROM THE ACCESS SITE SHEATH. LINT FOUND ON WIRES AND IN THE WATER BOWLS WAS MANUALLY REMOVED. NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335013 ↗
• MalfunctionFeb 16, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED BLUE TOWELS (PWTB04-STM) IN KIT (SAN43HCJMD) SHEDDING A LOT OF LINT DURING PERIPHERAL INTERVENTIONAL PROCEDURE. WHEN THE TOWELS STAY WET IN THE BOWL, BLUE LINT WAS FOUND AT THE BOTTOM OF THE BOWL AND REPORTEDLY IT CAUSES THE WIRES TO GET CAUGHT UP IN THE BLUE TOWELS. THE TOWELS WERE USED TO HOLD THE WIRES DOWN ON THE TABLE AND FOR EXCESS FLOW OF BLOOD FROM THE ACCESS SITE SHEATH. LINT FOUND ON WIRES AND IN THE WATER BOWLS WAS MANUALLY REMOVED. NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334909 ↗
• MalfunctionFeb 16, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED BLUE TOWELS (PWTB04-STM) IN KIT (SAN43HCJMD) SHEDDING A LOT OF LINT DURING PERIPHERAL INTERVENTIONAL PROCEDURE. WHEN THE TOWELS STAY WET IN THE BOWL, BLUE LINT WAS FOUND AT THE BOTTOM OF THE BOWL AND REPORTEDLY IT CAUSES THE WIRES TO GET CAUGHT UP IN THE BLUE TOWELS. THE TOWELS WERE USED TO HOLD THE WIRES DOWN ON THE TABLE AND FOR EXCESS FLOW OF BLOOD FROM THE ACCESS SITE SHEATH. LINT FOUND ON WIRES AND IN THE WATER BOWLS WAS MANUALLY REMOVED. NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334789 ↗
• MalfunctionFeb 16, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED BLUE TOWELS (PWTB04-STM) IN KIT (SAN43HCJMD) SHEDDING A LOT OF LINT DURING PERIPHERAL INTERVENTIONAL PROCEDURE. WHEN THE TOWELS STAY WET IN THE BOWL, BLUE LINT WAS FOUND AT THE BOTTOM OF THE BOWL AND REPORTEDLY IT CAUSES THE WIRES TO GET CAUGHT UP IN THE BLUE TOWELS. THE TOWELS WERE USED TO HOLD THE WIRES DOWN ON THE TABLE AND FOR EXCESS FLOW OF BLOOD FROM THE ACCESS SITE SHEATH. LINT FOUND ON WIRES AND IN THE WATER BOWLS WAS MANUALLY REMOVED. NO INJURY OR ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334626 ↗