NA BB8B96R14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000300692), received between Apr 30, 2024 and Apr 30, 2024 — classified as 2 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.

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.

• MalfunctionApr 30, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE NON-COLLARED SIDE OF THE VENT VALVE CONNECTOR. IT WAS STATED THAT THERE WAS MINIMAL PATIENT BLOOD LOSS AS A RESULT OF THE LEAK AND AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE LEAK. THE LEAK ORIGINATED FROM THE VALVE. THE CUSTOMER STATED THAT A COMPLETE CRACK/BREAK DID NOT OCCUR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19212523 ↗
• MalfunctionApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE NON-COLLARED SIDE OF THE VENT VALVE CONNECTOR. THERE WAS NO PATIENT BLOOD LOSS AS A RESULT. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE LEAK. THE LEAK ORGINATED FROM THE RED VENT VALVE COMPONENT. THE SAME LEAK APPEARED IN MULTIPLE PACKS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211656 ↗

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.