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NA BB8N34R5Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB8N34R5 PERF HL · Class 2

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.

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. Nov 16, 2016Terminated

    Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.

    Z-0826-2017 · Root cause: Process control · FDA record ↗

Other Pump, blood, cardiopulmonary bypass, non-roller type devices

All Pump, blood, cardiopulmonary bypass, non-roller type devices →

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