NA BB8B09R8Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB8B09R8 INFANT · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Oct 12, 2021Open, Classified
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Z-0491-2022 · Root cause: Under Investigation by firm · 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-1891-2021 · Apr 29, 2021 · Terminated
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Z-1895-2021 · Apr 29, 2021 · Terminated
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1884-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Z-1874-2021 · Apr 29, 2021 · Terminated
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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-1882-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1878-2021 · Apr 29, 2021 · Terminated
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1883-2021 · Apr 29, 2021 · Terminated
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Z-1881-2021 · Apr 29, 2021 · Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Z-1887-2021 · Apr 29, 2021 · Terminated
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, 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-1876-2021 · Apr 29, 2021 · Terminated
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

…and 10 more.

Device details

UDI-DI	`00763000347574`
Brand	NA
Model	BB8B09R8
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

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1 recall154 reports
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2 recalls19 reports
DLP™ 77008
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2 recalls9 reports
NA HY11W65R1
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2 recalls8 reports
DLP® 12113
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DLP® Aortic Root Cannula with Flow-Guard™ 11012
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EOPA™ 77622
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NA HY2V10R33
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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 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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