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N/A (REF 200344)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter , LARGE 4.0, 4 electrodes, 5mm spacing, 6F · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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-2176-2026 · Root cause: Process control · FDA record ↗

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-2195-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2192-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2174-2026 · Apr 10, 2026 · Open, Classified
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2186-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2197-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2191-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2175-2026 · Apr 10, 2026 · Open, Classified
    BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2180-2026 · Apr 10, 2026 · Open, Classified
    BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2194-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2184-2026 · Apr 10, 2026 · Open, Classified
    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2187-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2190-2026 · Apr 10, 2026 · Open, Classified
    Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
  • Z-2182-2026 · Apr 10, 2026 · Open, Classified
    BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

…and 12 more.

Other CATHETER, RECORDING, ELECTRODE, REPROCESSED devices

All CATHETER, RECORDING, ELECTRODE, REPROCESSED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.