CARDINAL HEALTH SAN41CCHKERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887488627731), received between Dec 4, 2020 and Dec 7, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2020Degraded

  CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) PROCEDURE . LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962807 ↗
• MalfunctionDec 7, 2020Degraded

  CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING A PACEMAKER IMPLANT PROCEDURE. LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962689 ↗
• MalfunctionDec 7, 2020Degraded

  CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING A PERIPHERAL INTERVENTION. LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962620 ↗
• MalfunctionDec 7, 2020Material Fragmentation

  CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING A DIAGNOSTIC PERIPHERAL INTERVENTION. LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962322 ↗
• MalfunctionDec 4, 2020Degraded

  CUSTOMER REPORTED LINT AND FUZZ COMING FROM THE STERILE TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN41CCHKE DURING A DIAGNOSTIC HEART CATHETERIZATION. LINT WAS FOUND ON THE WIRES AND BALLOONS DURING THE PROCEDURE. PIECES WERE REMOVED WITH IRRIGATION AND MANUAL REMOVAL. NO INJURY OCCURRED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945959 ↗