N/A (REF 401914)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825007294), received between Jul 13, 2017 and Mar 22, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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-2194-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE WHOLE BODY OF THE DEVICE LOOKED LIKE AN 'S' OR IT HAD SOME WAVES IN IT AND THAT OUT OF THE CONTAINER, THE DEVICE IMMEDIATELY WENT TO A WAVY FORM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592474 ↗
• MalfunctionJun 11, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE CATHETER WAS NOT WORKING PROPERLY. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION FROM THE FACILITY, HOWEVER NONE WERE PROVIDED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10146459 ↗
• InjuryJul 13, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER CURVE WAS UNABLE TO BE MANIPULATED WITH THE STEERING CABLE. AN ADDITIONAL CATHETER WAS REQUIRED TO ASSIST WITH THE REMOVAL OF THE DEVICE. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711927 ↗

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-2183-2026 · Apr 10, 2026 · Open, Classified
  BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2179-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2184-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2188-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2174-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2175-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2197-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2193-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2195-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2189-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2182-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 10 more.