N/A (REF 401932)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885825007355), received between Dec 21, 2016 and Dec 8, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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-2197-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT STEER TIGHT ENOUGH BY THE PHYSICIAN. AS REPORTED, THE DEVICE HAD MULTIPLE ATTEMPTS TO NAVIGATE FEMORAL VEIN TO CS THAT WERE UNSUCCESSFUL. ICE WAS INTRODUCED TO HELP GUIDE THE DEVICE TO THE PROPER LOCATION. ATTEMPTS WERE UNSUCCESSFUL. UPON REPLACEMENT WITH ANOTHER STRYKER DUADECA, ACCESS TO THE CS WAS GAINED UPON THE FIRST ATTEMPT. THE DEVICE WAS REPLACED WITH A STRYKER DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 3-5 MINUTES AS ACCESS WAS ATTEMPTED AND REPLACEMENT WAS INTRODUCED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751090 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT JUST CUT TIP - BROKEN. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21562561 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS POOR STEERABILITY IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562229 ↗
• MalfunctionMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS POOR STEERABILITY IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562050 ↗
• MalfunctionAug 14, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED FOR THE CATHETER THAT THE ITEM DIDN'T FUNCTION PROPERLY MECHANICALLY DURING PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986568 ↗
• MalfunctionDec 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PRODUCT WAS BENT AND UNABLE TO HOLD SHAPE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING 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 12980879 ↗
• MalfunctionSep 14, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PHYSICIAN WAS ATTEMPTING TO USE A REPROCESSED ABBOTT LIVEWIRE DIAGNOSTIC EP CATHETER DURING THE PROCEDURE, BUT REALIZED THAT THE CATHETER WAS NOT DEFLECTING CORRECTLY, AND THERE WAS A KINK/BEND BETWEEN SOME OF THE ELECTRODES ON THE CATHETER THAT PREVENTS THE CATHETER FROM RETURNING TO A STRAIGHT POSITION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 5 MINUTES WHILE STAFF WENT TO RETRIEVE A NEW REPLACEMENT CATHETER FROM THE STOREROOM. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467096 ↗
• MalfunctionJul 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING A SVT ABLATION PROCEDURE PHYSICIAN ATTEMPTED TO USE A REPROCESSED ABBOTT LIVEWIRE DUODECA WITH SPACING AND NOTED THAT THE CATHETER WAS NOT CURVING CORRECTLY AND HAD A BEND/KINK BETWEEN A SET OF ELECTRODES THAT CAUSED A DISSATISFYING CURVE SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 3 TO 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250406 ↗
• MalfunctionMar 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER BECAME KINKED AS IT WAS BEING ADVANCED UP TO THE HEART. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780787 ↗
• MalfunctionMar 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER BENT WHEN THE PHYSICIAN ATTEMPTED TO DEFLECT IT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER REVEALED THE ELECTROPHYSIOLOGY CATHETER HAD A KINK AMIDST THE ELECTRODES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780786 ↗
• InjuryJan 15, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER STEERING MECHANISM FAILED AND THE DOCTOR HAD DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT'S BODY. THE CATHETER WAS STUCK IN THE PATIENT'S HEART AND WAS NOT DEFLECTING. TWO ADDITIONAL PHYSICIANS AND TWO ADDITIONAL DEVICES WERE REQUIRED TO REMOVE THE ELECTROPHYSIOLOGY CATHETER. THERE WAS A DELAY IN THE CASE OF APPROXIMATELY 45 MINUTES TO REMOVE AND REPLACE THE DEVICE. THE PATIENT WAS FINE AND THERE WAS NO PATIENT INJURY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591071 ↗
• MalfunctionJul 12, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS FRACTURED; THERE WAS A MANEUVERABILITY ISSUE PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786003 ↗
• MalfunctionJul 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS KINKED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755603 ↗
• MalfunctionMar 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE CASE, THE ELECTROPHYSIOLOGY CATHETER BECAME EXTREMELY BENT AND WOULD NOT READ PROPERLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392790 ↗
• MalfunctionFeb 21, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER KINKED IN WITHIN THE PATIENT'S HEART. THEY HAD TO MAKE SEVERAL MANEUVERS TO UNKINK AND REMOVE IT FROM THE PATIENT'S HEART. THE DR. USED ANOTHER DEVICE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358108 ↗
• MalfunctionFeb 21, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT AN ELECTROPHYSIOLOGY CATHETER WAS KINKED, AND THE KINK HAD TO BE MANIPULATED TO REMOVE THE DEVICE FROM THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY ONE MINUTE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357834 ↗
• MalfunctionFeb 14, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER HAD A FAULTY DEFLECTION MECHANISM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339203 ↗
• MalfunctionDec 12, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THE TIP OF THE ELECTROPHYSIOLOGY CATHETER BECAME BENT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155120 ↗
• MalfunctionSep 27, 2017Difficult To Position; Difficult To Position

  IT WAS REPORTED THERE WAS A STEERING ISSUE WITH THE ELECTROPHYSIOLOGY CATHETER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6898975 ↗
• MalfunctionFeb 9, 2017Break

  IT WAS REPORTED THE CATHETER WAS MISSHAPED/BROKEN. THERE WAS A MINIMAL DELAY TO REPLACE THE DEVICE. IT WAS STATED BY THE CUSTOMER THE DOCTOR MARKED "POSSIBLE PATIENT HARM" ON HIS SHEET. NO ADDITIONAL DETAILS WERE PROVIDED AS THAT WAS ALL THE INFORMATION THE CUSTOMER HAD. THERE WAS NO MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6315884 ↗
• MalfunctionDec 21, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DOCTOR HAD TROUBLE STEERING THE DEVICE INTO THE CORONARY SINUS DURING AN AFIB PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6194172 ↗

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-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2177-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
• 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-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2194-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2180-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2174-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2188-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2182-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 10 more.