CARDINAL HEALTH SCV21IMNSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195594677244), received between Sep 19, 2022 and Sep 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THAT DURING A PERMANENT PACEMAKER PLACEMENT, THERE WAS LINTING WITHIN THE IMPLANT PACK SCV21IMNSC. CUSTOMER IS UNSURE THE SOURCE BUT STATES POSSIBLY FROM THE PACEMAKER DRAPE A29013AN SINCE THE GUIDE WIRE WAS ON THE DRAPE WITH A WET TOWEL ON TOP TO KEEP THE WIRE FROM JUMPING OFF THE TABLE. THERE WAS NO ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447582 ↗
• MalfunctionSep 19, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THAT DURING A PERMANENT PACEMAKER PLACEMENT, THERE WAS LINTING WITHIN THE IMPLANT PACK SCV21IMNSC. CUSTOMER IS UNSURE THE SOURCE BUT STATES POSSIBLY FROM THE COTTON TOWELS PWTB04-STM SINCE THE GUIDE WIRE WAS ON THE DRAPE WITH A WET TOWEL ON TOP TO KEEP THE WIRE FROM JUMPING OFF THE TABLE. THERE WAS NO ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447556 ↗