N/A (REF 401904)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885825007263), received between Sep 16, 2019 and Dec 22, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

25 other recalls cover devices cleared under the same FDA submission (K052603); 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.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   Incomplete seals on sterile product

   Z-2191-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Electrical /Electronic Property Problem; Mechanical Problem; Use of Device Problem; Electrical /Electronic Property Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LIVEWIRE DUODECA CATHETER. THE PINS DID NOT HAVE SIGNAL AND THE CATHETER WAS DIFFICULT TO STEER AND POSITION PROPERLY. AS REPORTED, THIS OCCURRED DURING AN AFIB ABLATION AND ADDED TO THE FLUORO TIME AND THE TIME THE PATIENT WAS UNDER GENERAL ANESTHESIA, AFFECTING BOTH THE PATIENT AND THE STAFF. THE CATHETER WAS REPLACED WITH AN OEM DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS THE TIME OF GRABBING THE OEM DEVICE AND USING THAT DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23870700 ↗
• MalfunctionDec 22, 2025Poor Quality Image; Use of Device Problem; Poor Quality Image; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LIVEWIRE DUODECA CATHETER. THE PINS DID NOT HAVE SIGNAL AND THE CATHETER WAS DIFFICULT TO STEER AND POSITION PROPERLY. AS REPORTED, THIS OCCURRED DURING AN AFIB ABLATION AND ADDED TO THE FLUORO TIME AND THE TIME THE PATIENT WAS UNDER GENERAL ANESTHESIA, AFFECTING BOTH THE PATIENT AND THE STAFF. THE CATHETER WAS REPLACED WITH AN OEM DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS THE TIME OF GRABBING THE OEM DEVICE AND USING THAT DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23870697 ↗
• MalfunctionApr 21, 2025Positioning Problem

  DURING ATRIAL FLUTTER ABLATION PROCEDURE, IT WAS REPORTED THAT LIVEWIRE COULD NOT EASILY BE PLACED IN DESIRED LOCATION. AT ONE POINT, DIFFERENT SHEATHS WERE USED AS DILATORS, EVENTUALLY IT WAS DETERMINED THAT THE CATHETER PLACEMENT WAS NOT ADEQUATE, HAD TO BE REMOVED, AND DR [REDACTED] ASKED FOR ANOTHER LIVEWIRE. LIVEWIRE IN REPORT WAS REMOVED AND ANOTHER PLACED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873148 ↗
• MalfunctionMar 31, 2025Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THE CATHETER HAD A CURVE ON THE WIRE WHICH CREATED A KINK. AS REPORTED, STAFF WERE NOT ABLE TO CANNULATE THE CORONARY SINUS. THE DEVICE CAME OUT THE BOX WITH THE ISSUE AND A NEW NON-REPROCESSED REPLACEMENT WAS USED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733476 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED CATHETER WOULD NOT DEFLECT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846794 ↗
• MalfunctionDec 16, 2020Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE CATHETER WAS 'TOO FLIMSY TO MANIPULATE'. IT WAS REMOVED AND REPLACED. THE CATHETER WAS FLIMSY AND LIKE A NOODLE WHEN MANIPULATED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME LENGTH IS UNKNOWN. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016476 ↗
• InjurySep 25, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER GOT STUCK IN THE RIGHT VENTRICULAR APEX WHILE ADVANCING TO THE CORONARY SINUS CAUSING SOME TRICUSPID REGURGITATION. A SHEATH HAD TO BE INSERTED TO REMOVE THE CATHETER. THE MEDWATCH FORM SELECTED "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)", HOWEVER NO FURTHER DETAILS WERE PROVIDED FROM THE CUSTOMER ABOUT THE EVENT. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, HOWEVER NONE WERE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 10590447 ↗
• MalfunctionSep 16, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE REPROCESSED LIVE WIRE ELECTROPHYSIOLOGY CATHETER WOULD NOT STEER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070488 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052603. One submission often covers many models, so check the product and lot details in each record.

• Z-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2199-2026 · Apr 10, 2026 · Open, Classified
  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2178-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2181-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2195-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2180-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2179-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2197-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 10 more.