CARDINAL HEALTH SAN43PMMFKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488908717), received between Aug 4, 2021 and Aug 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2021Material Discolored; Product Quality Problem; Material Separation; Material Separation

  DOCTOR REPORTED AFTER DRYING HANDS WITH COTTON TOWEL PWTB04-STM FROM THE FEMORAL ANGIOGRAPHY PACK SAN30AFMMF DURING AN INTERVENTIONAL CARDIOLOGY PROCEDURE HE NOTICED HIS GLOVES HAD BLUE LINT. NO ADVERSE EVENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277494 ↗
• MalfunctionAug 4, 2021Contamination; Device Contaminated During Manufacture or Shipping; Contamination

  CUSTOMER REPORTED CLUMPS OF LINT AND A HAIR WERE FOUND IN THE PACEMAKER PACK SAN43PMMFK. NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277382 ↗