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NA HY9D36R1Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK HY9D36R1 LPS CUSTM · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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
2

Summary

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

2 FDA recall records 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Oct 12, 2021Class IIOpen, Classified

    Product is labeled as non-pyrogenic but endotoxin testing was not performed.

    Z-0491-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Nov 16, 2016Class IITerminated

    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 · Recall details · FDA record ↗

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

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page