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Affinity NT™ CB511Recalls & reported problems

Medtronic, Inc. · OXYGENATOR CB511 AFFINITY BIOACT 4PK · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169767843), received between Aug 5, 2022 and Aug 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THERE WAS ABNORMAL LEAKAGE. LEAK IS FROM THE TEMPERATURE MONITORING PORT. THE DEVICE USE WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 15173519 ↗

Other OXYGENATOR, CARDIOPULMONARY BYPASS devices

All OXYGENATOR, CARDIOPULMONARY BYPASS devices →

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