Blazer™ Dx-20 M00420SL2520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729780502), received between Jun 27, 2018 and Jun 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Sense” (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.

• MalfunctionJun 27, 2018Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-JUNE-2018. IT WAS REPORTED THAT SIGNAL ISSUES OCCURRED. DURING THE PROCEDURE, IT WAS NOTED THAT THE BLAZER¿ DX-20 CATHETER WAS NOT FUNCTIONING. IT WAS PLUGGED IN BUT NO SIGNALS WERE NOTED. THEN, ANOTHER CABLE WAS USED BUT THE PROBLEM WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A PERFORATION OF THE SHAFT AT THE DISTAL SECTION APPROXIMATELY AT 6.5 CM FROM THE DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641475 ↗