NA BB8D44R9Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB8D44R9 UNIV H/L · 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 00763000924133), received between Oct 8, 2024 and Aug 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Fluid/Blood Leak1
Packaging Problem1

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.

MalfunctionAug 13, 2025Packaging Problem; Packaging Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED, AND THE STERILITY BARRIER WAS DAMAGED. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. SEE ATTACHED PHOTO. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791674 ↗
MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK COMING FROM THE PRE ROLLAR HEAD. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395740 ↗

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-1894-2021 · Apr 29, 2021 · Terminated
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-1889-2021 · Apr 29, 2021 · Terminated
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, 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-1881-2021 · Apr 29, 2021 · Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Z-1886-2021 · Apr 29, 2021 · Terminated
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, 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-1878-2021 · Apr 29, 2021 · Terminated
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1880-2021 · Apr 29, 2021 · Terminated
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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-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.

…and 10 more.

Device details

UDI-DI	`00763000924133`
Brand	NA
Model	BB8D44R9
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	In Commercial Distribution
Record updated	Jan 8, 2024

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
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
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
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
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 HY11R00R6
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 · 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.

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