CARDINAL HEALTH SANCGPMAB3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594062958), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A CARDIAC PROCEDURE THERE WAS SHREDDING FROM GAUZE, C-NXR4416A, FROM PACEMAKER PACK, SANCGPMAB3. THERE WAS NO PATIENT INJURY. THE SHRED WAS SEEN NEXT TO AN OPEN POCKET AND WAS REMOVED WITH ADSON FORCEPS. IT DID NOT CAUSE ANY DELAYS. NO FURTHER CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903060 ↗