N/A (REF 200131)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825002930), received between Jul 19, 2021 and Sep 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).

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

27 other recalls cover devices cleared under the same FDA submission (K030187); 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-2175-2026 · 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.

• MalfunctionSep 4, 2024Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam; Device Damaged Prior to Receipt by User; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT FOR THE CATHETER: POOR STEERING. 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 20139669 ↗
• MalfunctionJun 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE DEVICE WOULD NOT STAY IN CS AND MAINTAIN CURVE AND THAT THE CUSTOMER HAD A HARD TIME STEERING. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 17099542 ↗
• MalfunctionJul 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE CATHETER HAS A BENT TIP. 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 12189611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030187. One submission often covers many models, so check the product and lot details in each record.

• Z-0085-2027 · Aug 18, 2026 · Open, Classified
  BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
• Z-2199-2026 · Apr 10, 2026 · Open, Classified
  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2190-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2192-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2198-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2185-2026 · Apr 10, 2026 · Open, Classified
  CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2179-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2187-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2178-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2191-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2196-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2176-2026 · Apr 10, 2026 · Open, Classified
  BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2181-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2186-2026 · Apr 10, 2026 · Open, Classified
  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Z-2182-2026 · Apr 10, 2026 · Open, Classified
  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 12 more.