N/A (REF 401451)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825006679), received between Oct 3, 2016 and Oct 3, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

29 other recalls cover devices cleared under the same FDA submission (K012708); 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.

• MalfunctionOct 3, 2016Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE WIRES BECAME EXPOSED ON THE DEVICE DURING PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5995413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012708. One submission often covers many models, so check the product and lot details in each record.

• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2174-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2199-2026 · Apr 10, 2026 · Open, Classified
  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2178-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2197-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2182-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2177-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2185-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2181-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 14 more.