Custom Perfusion System HY8L55R5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169572263), received between Jun 8, 2023 and Apr 19, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

3 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 12, 2022Class IIOpen, 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 · Recall details · FDA record ↗

2. Dec 12, 2022Class IIOpen, 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 · Recall details · FDA record ↗

3. Nov 16, 2016Class IITerminated

   Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.

   Z-0826-2017 · Root cause: Process control · Recall details · 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.

• MalfunctionApr 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE LOCATION IN WHICH THE TUBING WAS CONNECTED TO THE LUER PORT. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141549 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER WAS PRIMING THE CIRCUIT. WHEN FLUID ENTERED THE CONE DURING GRAVITY PRIMING, IT BEGAN TO LEAK FROM WHAT APPEARED TO BE A CRACK AT THE TOP OF THE INLET CONNECTOR NEAR WHERE THE TUBING WAS CONNECTED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE PACKAGING OF THE PACK WAS INTACT WITH NO DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341434 ↗
• MalfunctionJun 8, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED THAT THE CUSTOMER WAS PRIMING THE CIRCUIT PRIOR TO PATIENT ENTERING THE ROOM AND FLUID LEAK WAS FOUND COMING FROM THE PUMP HEAD DURING GRAVITY PRIME. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085301 ↗