Affinity Fusion® BB841 (UDI 00643169178144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169178144), received between Mar 14, 2023 and Aug 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED A LEAK FROM THE MODULE DURING BYPASS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THERE WAS APPROXIMATELY 10MLS OF BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570961 ↗
• MalfunctionMar 14, 2023Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THE DE-FOAMER OVERFLOWED AND/OR WAS OBSTRUCTED FROM THE RECIRCULATION LINE COMING IN. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A POSSIBLE OBSTRUCTION INSIDE THE RESERVOIR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS USED TO COMPLETE THE PROCEDURE, IT WAS MOVED TO ANOTHER PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538524 ↗