Affinity® CB511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994529091), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K000430); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED THAT UPON PRIMING THE CPB CIRCUIT A LEAK WAS OBSERVED AT THE TEMP PORT OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000430. One submission often covers many models, so check the product and lot details in each record.

• Z-1922-2008 · May 9, 2008 · Terminated
  Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.