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MEDLINE 402004RHRecalls & reported problems

Medline Industries, Inc. · SJM DIAG EP CATH FIXD CRD2 4POLE 5MM 6FR · Class 2

2 open recalls name 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
2

Summary

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

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 22, 2025Open, Classified

    These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

    Z-1322-2026 · Root cause: Under Investigation by firm · FDA record ↗

  2. Jul 14, 2025Open, Classified

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

    Z-2460-2025 · Root cause: Under Investigation by firm · 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

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.