NA BB10J00R16Recalls & reported problems

Medtronic, Inc. · CUSTOM PACK BB10J00R16 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 00199150022489), received between Jan 13, 2026 and Jan 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 Separation2

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 15, 2026Material Separation
IT WAS REPORTED THAT THE CUSTOM TUBING PACK, HAD A LOOSE CONNECTOR. THE 1/4 CONNECTOR INSIDE THE STERILE CLAMSHELL OF THIS PACK HAS RECENTLY BEEN ¿LOOSER THAN NORMAL¿. THE CUSTOMER WANTS THE TUBING PUSHED OVER 2 BARBS OF THE CONNECTOR ON BOTH SIDES BUT NOT SOLVENT BONDED OR TIE BANDED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24078612 ↗
MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACK, THE CONNECTOR WAS LOOSE. THE 1/4 CONNECTOR INSIDE THE STERILE CLAMSHELL OF THIS PACK HAS RECENTLY BEEN ¿LOOSER THAN NORMAL¿. THE CUSTOMER WANTS THE TUBING PUSHED OVER 2 BARBS OF THE CONNECTOR ON BOTH SIDES BUT NOT SOLVENT BONDED OR TIE BANDED. THE DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051282 ↗

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-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-1881-2021 · Apr 29, 2021 · Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1893-2021 · Apr 29, 2021 · Terminated
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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-1872-2021 · Apr 29, 2021 · Terminated
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, 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-1875-2021 · Apr 29, 2021 · Terminated
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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-1882-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1879-2021 · Apr 29, 2021 · Terminated
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

…and 10 more.

Device details

UDI-DI	`00199150022489`
Brand	NA
Model	BB10J00R16
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	Jun 2, 2025

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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