NA BB8J66R11Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB8J66R11 FUSION · 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

Feb 4, 2016Terminated
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.
Z-1023-2016 · Root cause: Component design/selection · FDA record ↗

Device details

UDI-DI	`00643169657755`
Brand	NA
Model	BB8J66R11
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

CENTRIMAG MOTOR 102956
Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
2 recalls4 deaths591 reports
Impella Impella 5.0 AIC Pump Set
Abiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
3 recalls56 deaths256 reports
CentriMag™ 102953
Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
1 recall35 deaths209 reports
Impella Impella LD AIC Pump Set
Abiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
3 recalls9 deaths57 reports
NA HY8M65R2
Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
4 recalls0 reports
Custom Perfusion System HY8L55R5
Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
3 recalls3 reports
Custom Perfusion System BB6U40R11
Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
2 recalls1 report
NA HY9D36R1
Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type
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.

How reports and recalls are matched · Editorial policy · Report an error on this page