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MEDLINE 401453RHRecalls & reported problems

Medline Industries, Inc. · SJM SUPREME CATH FIXD DAO 4POLE 2/5/2 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.

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. 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 ↗

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.