NA HY10J00R15Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK HY10J00R15 1/4 E C L S · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000605285), received between Oct 2, 2024 and Jan 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (1 report).

25 other recalls cover devices cleared under the same FDA submission (K171979); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Deformation1
Material Separation1
Misassembled During Installation1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionJan 17, 2025Material Separation; Misassembled During Installation; Material Separation; Misassembled During Installation
IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACK , THE ARTERIAL AND VENOUS LINES INSIDE THE CLAMSHELL, WHICH WERE SUPPOSED TO BE SECURED TO THE 1/4¿ STRAIGHT CONNECTOR, WERE FOUND TO HAVE ONE SIDE OF THE CONNECTOR DISCONNECTED FROM THE TUBING, LEAVING THE TUBING LOOSE INSIDE THE CLAMSHELL. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21176731 ↗
MalfunctionOct 2, 2024Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF CUSTOM TUBING PACK, IT WAS REPORTED THAT THE PERFUSION ADAPTER (1/4 X MALE LUER) THAT IS ON THE LINE THAT EXITS THE BOTTOM OF THE PIXIE CVR DID NOT TIGHTEN SECURELY TO THE FEMALE LUER PORT OF THE 3 WAY STOPCOCK. THE CUSTOMER HAD TO GO AROUND AND TIGHTEN THEM MULTIPLE TIMES DURING PRIMING SINCE IT WOULD NOT STAY TIGHT AND SECURE. SEE ATTACHED PHOTO. THE DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20349978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171979. One submission often covers many models, so check the product and lot details in each record.

Z-1876-2021 · Apr 29, 2021 · Terminated
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Z-1889-2021 · Apr 29, 2021 · Terminated
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Z-1872-2021 · Apr 29, 2021 · Terminated
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Z-1877-2021 · Apr 29, 2021 · Terminated
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Z-1879-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Z-1883-2021 · Apr 29, 2021 · Terminated
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Z-1873-2021 · Apr 29, 2021 · Terminated
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Z-1884-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Z-1888-2021 · Apr 29, 2021 · Terminated
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Z-1890-2021 · Apr 29, 2021 · Terminated
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Z-1882-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Z-1891-2021 · Apr 29, 2021 · Terminated
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Z-1871-2021 · Apr 29, 2021 · Terminated
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Z-1892-2021 · Apr 29, 2021 · Terminated
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Z-1881-2021 · Apr 29, 2021 · Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.

…and 10 more.

Device details

UDI-DI	`00763000605285`
Brand	NA
Model	HY10J00R15
Company	Medtronic, Inc.
Product code	DWF · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Class	Class 2
FDA submission	K171979
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	Apr 2, 2026

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.

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All Catheter, cannula and tubing, vascular, cardiopulmonary bypass 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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