Custom Perfusion System HY0W84R28Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK HY0W84R28 KD OPEN · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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

Nov 16, 2016Terminated
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 · FDA record ↗

Device details

UDI-DI	`00643169587106`
Brand	Custom Perfusion System
Model	HY0W84R28
Company	Medtronic, Inc.
Product code	KFM · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Class	Class 2
FDA submission	K973011
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 8, 2022

Device type (GMDN): Cardiopulmonary bypass system blood tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Other PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices

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Impella Impella LD AIC Pump Set
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NA HY8M65R2
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4 recalls0 reports
Custom Perfusion System HY8L55R5
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3 recalls3 reports
Custom Perfusion System BB6U40R11
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NA HY9D36R1
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2 recalls0 reports

All PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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