NA BIOD6-DR-005-RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551006408), received between Sep 14, 2020 and Sep 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K043513); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE AND THE BLUE COATING ON THE TIP OF CATHETER WAS SHEARED OFF. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043513. One submission often covers many models, so check the product and lot details in each record.

• Z-0555-2009 · Aug 8, 2008 · Terminated
  EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intrac