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MEDLINE 402012RHRecalls & reported problems

Medline Industries, Inc. · SJM SUPREME CATH FIXED CRD2 4POLE 5MM 4F · 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.

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 ↗

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.