HF Std Pack with BC 60 Plus T8036Recalls & reported problems

Datascope Corp. · BC 60 Plus · 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.

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

May 22, 2017Class IITerminated
55 kits were distributed after their expiration date of September 2015.
Z-0490-2018 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Device details

UDI-DI	`00607567206489`
Brand	HF Std Pack with BC 60 Plus
Model	T8036
Catalog no.	701066990
Company	Datascope Corp.
Product code	DWE · Tubing, Pump, Cardiopulmonary Bypass
Class	Class 2
FDA submission	None listed
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 Tubing, Pump, Cardiopulmonary Bypass devices

NA BB9L72R1
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
3 recalls0 reports
NA BB8M16R3
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls1 report
NA BB7P48R4
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports
NA BB8L58R3
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports
NA BB7P46R4
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports
NA BB8D40R3
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports
NA BB8B70R7
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports
NA BB8T77R2
Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
2 recalls0 reports

All Tubing, Pump, 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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