superDimension SDMDK1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521200524), received between May 13, 2020 and May 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Application Program Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 13, 2020Entrapment of Device; Migration or Expulsion of Device; Application Program Problem; Entrapment of Device; Migration or Expulsion of Device; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN HAD ISSUES DEPLOYING THE FIDUCIALS, EACH ONE MIGRATED UPON DEPLOYING OUT OF THE END OF THE MARKER DELIVERY KITS. WHEN TECH WAS LOADING THE FIDUCIAL INTO THE FIRST MARKER DELIVERY KIT IT BECAME LODGED IN THE PROXIMAL HUB AND COULD NOT ADVANCE THE GUIDE WIRE. THE SUPERD PORTION WAS NOT COMPLETED. IT WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10054090 ↗
• InjuryMay 13, 2020Positioning Failure; Migration or Expulsion of Device; Application Program Problem; Positioning Failure; Migration or Expulsion of Device; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN HAD ISSUES DEPLOYING THE FIDUCIALS, EACH ONE MIGRATED UPON DEPLOYING OUT OF THE END OF THE MARKER DELIVERY KITS. WHEN TECH WAS LOADING THE FIDUCIAL INTO THE FIRST MARKER DELIVERY KIT IT BECAME LODGED IN THE PROXIMAL HUB AND COULD NOT ADVANCE THE GUIDE WIRE. THE SUPERD PORTION WAS NOT COMPLETED. IT WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10054073 ↗