Medline 227204RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277389502), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionJan 10, 2017Material Fragmentation; Material Fragmentation

  WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ABLATION WAND DETACHED DURING USE. IT IS UNKNOWN IF THE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM AND NO INFORMATION IF MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6239668 ↗