NA BB8J66R17Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169750883), received between Mar 29, 2022 and Jan 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED THAT ONE OF THE Y CONNECTORS IN THE LINE WAS CLOGGED, AND FLUID WOULD NOT PASS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490950 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK OF PRIMING FLUID FROM THE ARTERIAL PORT CONNECTED TO THE OXYGENATOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. NO AIR WAS SEEN IN THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163062 ↗
• MalfunctionMar 29, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THERE WAS A CRACK AND LEAK FROM THE OUTLET PORT OF THE MYOTHERM. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936738 ↗