NA CB10Y89R10Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK CB10Y89R10 ECC 3/8 A/V · Class 2

Data updated Oct 18, 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.

24 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 18, 2026.

Recalls naming this device

Apr 29, 2021Class IITerminated
Specific lots may have been manufactured with insufficient or incomplete welds.
Z-1891-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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-1892-2021 · Apr 29, 2021 · Terminated
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Z-1893-2021 · Apr 29, 2021 · Terminated
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Z-1875-2021 · Apr 29, 2021 · Terminated
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Z-1885-2021 · Apr 29, 2021 · Terminated
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Z-1880-2021 · Apr 29, 2021 · Terminated
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-1883-2021 · Apr 29, 2021 · Terminated
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Z-1884-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Z-1873-2021 · Apr 29, 2021 · Terminated
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Z-1881-2021 · Apr 29, 2021 · Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1894-2021 · Apr 29, 2021 · Terminated
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Z-1876-2021 · Apr 29, 2021 · Terminated
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Z-1895-2021 · Apr 29, 2021 · Terminated
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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.

…and 9 more.

Device details

UDI-DI	`00763000499105`
Brand	NA
Model	CB10Y89R10
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.

Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices

DLP™ 77010
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall154 reports
EOPA™ 77422
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2 recalls19 reports
DLP™ 77008
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls9 reports
NA HY11W65R1
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls8 reports
DLP® 12113
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2 recalls6 reports
DLP® Aortic Root Cannula with Flow-Guard™ 11012
Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
2 recalls5 reports
EOPA™ 77622
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls4 reports
NA HY2V10R33
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls3 reports

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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