NA BAR400001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551014007), received between Dec 19, 2019 and Dec 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012523); 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.

• MalfunctionDec 19, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER VIKING QUADRIPOLAR JOSEPHSON CATHETER AND THE TYVEK COVER WAS NOT SEALED TO THE PLASTIC TRAY ON INNER PACKAGING WHEN THE DEVICE WAS REMOVED FROM THE OUTER BOX PACKAGING. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THE DEVICE DID NOT CONTACT THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496380 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012523. 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