NA HY7V82R20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000316976), received between May 16, 2023 and Nov 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 FDA recall records name this device's identifier, 2 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-1028-2023 · Root cause: Process change control · FDA record ↗

2. 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.

• MalfunctionNov 26, 2024Obstruction of Flow; Contamination /Decontamination Problem; Obstruction of Flow; Contamination /Decontamination Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE FLOW WAS OBSTRUCTED AND COULD NOT GO THROUGH. THE CUSTOMER OBSERVED THAT THE PRESSURE LINE NEAR THE ARTERIAL LINE HAD ADHESIVE IN THE LUER. THERE WAS NO CLOTTING ISSUES, SO THE CUSTOMER DID NOT TAKE NOTE ON THE HEPARIN USAGE. THE ISSUE DID NOT WORSEN OVER TIME. THE AFFECTED PRESSURE LINE 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 20787430 ↗
• MalfunctionMay 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE PRESSURE DOME LEAKED AND BLOOD FILLED THE TRANSDUCER. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT LEAK DID NOT OCCUR IN MULTIPLE PACKS. THERE WAS NO VISIBLE AIR IN THE SYSTEM/ TUBING. THE DIAPHRAGM SEEMS TO HAVE SEPARATED BECAUSE THE BLOOD ENDED UP ON THE SIDE THAT WAS SUPPOSED TO ONLY HAVE AIR. THERE WAS NO DAMAGE TO THE DEVICE AND PACKAGING MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CIRCUIT WAS PRIMED WITH PLASMALYTE, AND THEN WENT ON TO PUMP WHICH THEN MIXED WITH THE BLOOD. CUSTOMER WENT TO READ THE PRESSURE TRANSDUCER AND NOTICED THE BLOOD WAS IN THE DOME AND CUSTOMER HAD NOT TURNED THE STOPCOCK TO READ IT YET. THERE WAS NO ADVERSE EFFECTS, CUSTOMER JUST REPLACED THE PRESSURE LINE AND THERE WAS NO ADDITIONAL BLOOD LOSS OR EXTERNAL LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938338 ↗

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.