TRILLIUM® AFFINITY NT® 95217Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994375636), received between Aug 10, 2021 and Jun 13, 2023 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K191029, K973760); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED A BLOOD LEAK FROM THE AFFINITY NT OXYGENATOR ABOUT 20 MINUTES IN TO BYPASS. THE CUSTOMER STATED THAT THE LEAK WAS FROM THE MIDDLE AND LOWER PART OF THE OXYGENATOR. THE DEVICE WAS REPLACED. THE EXACT AMOUNT OF BLOOD LOST COULD NOT BE PROVIDED BUT THE CUSTOMER STATED THAT A LOT OF BLOOD WAS NOT LOST. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING. NO DAMAGE TO THE OXYGENATOR WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117580 ↗
• InjuryAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCE EXCESSIVE BLOOD LOSS DUE TO A LEAK FROM THE OXYGENATOR. THE PATIENT WAS GIVEN A TWO BAGS OF PLASMA INFUSION AS TREATMENT. THE OXYGENATOR WAS USED TO COMPLETE THE PROCEDURE, TO AVOID STOPPING THE CARDIOPULMONARY BYPASS. THE PATIENT OUTCOME WAS REPORTED AS ALIVE-NO INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12301344 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191029, K973760. One submission often covers many models, so check the product and lot details in each record.

• Z-0476-2008 · Oct 1, 2007 · Terminated
  Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
• Z-0815-04 · Mar 25, 2004 · Terminated
  Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R