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NA BB8P01R7Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB8P01R7 PUMP TBL · 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. Dec 12, 2022Open, Classified

    An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

    Z-1027-2023 · Root cause: Process change 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.