MEDLINE 401966RHRecalls & reported problems

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.

3 other recalls cover devices cleared under the same FDA submission (K221067); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 14, 2025Open, Classified

   Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

   Z-2460-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221067. One submission often covers many models, so check the product and lot details in each record.

• Z-1321-2026 · Dec 22, 2025 · Open, Classified
  Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electr
• Z-2610-2025 · Jul 31, 2025 · Open, Classified
  Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH
• Z-1460-2025 · Feb 6, 2025 · Open, Classified
  Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R