Small Adult CPB BO-TOP 38600Recalls & reported problems

Datascope Corp. · HMO 51000 (BO coated) Quadrox i Small Adult with integral filter, BO-VHK 71000 Venous Reservoir, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter · 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

Jul 27, 2017Class IITerminated
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Z-2180-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Device details

UDI-DI	`00607567210004`
Brand	Small Adult CPB
Model	BO-TOP 38600
Catalog no.	701056035R01
Company	Datascope Corp.
Product code	DWF · Catheter, Cannula And Tubing, Vascular, 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.

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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
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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