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SJM™ C0510Recalls & reported problems

St. Jude Medical, Inc. · With EnCap Technology · Class 2 · Implant

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.

1 other recall cover devices cleared under the same FDA submission (K963967); 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. Oct 9, 2025Open, Classified

    The impacted lot may not meet the required tensile strength specification.

    Z-0532-2026 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963967. One submission often covers many models, so check the product and lot details in each record.

  • Z-0531-2026 · Oct 9, 2025 · Open, Classified
    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices

All PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices →

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