NA BB4Z62R19Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000275341), received between Jul 17, 2023 and Jul 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171308); 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.

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

• MalfunctionJul 17, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED ISSUES WITH THE CONNECTOR TO TUBING CONNECTIONS ON THE ARTERIAL SIDE OF THE CIRCUIT NOT BEING STRONG ENOUGH, MEANING THEY ARE EXTREMELY LOOSE. THEY WERE ABLE TO MANIPULATE THE TUBING ON THE CONNECTOR AND ACTUALLY MOVE AIR INTO THE CIRCUIT (THIS WAS DONE OFF BYPASS AND THE PATIENT WAS NOT INVOLVED OR HARMED). 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 17332890 ↗
• MalfunctionJul 17, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED ISSUES WITH THE CONNECTOR TO TUBING CONNECTIONS ON THE ARTERIAL SIDE OF THE CIRCUIT NOT BEING STRONG ENOUGH, MEANING THEY ARE EXTREMELY LOOSE. THEY WERE ABLE TO MANIPULATE THE TUBING ON THE CONNECTOR AND ACTUALLY MOVE AIR INTO THE CIRCUIT (THIS WAS DONE OFF BYPASS AND THE PATIENT WAS NOT INVOLVED OR HARMED). 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 17332798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.