Devices

Device Recall Terumo Coronary Ostia Cannulae

Model / Serial
Part Number 804115 lot 0520497, 0528973, 0569610, 0606841.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
Product Description
804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Manufacturer
Terumo Cardiovascular Systems Corporation
1 Event
- Recall of Device Recall Terumo Coronary Ostia Cannulae

Manufacturer

Terumo Cardiovascular Systems Corporation

Manufacturer Address
Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Terumo Coronary Ostia Cannulae

Model / Serial
Part Number 804117 Lot 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
Product Description
804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment
Manufacturer
Terumo Cardiovascular Systems Corporation

Device Recall Terumo Coronary Ostia Cannulae

Model / Serial
Part Number 804159 lot 0520498, 0528975, 0567050, 0582503, 0617088, 0624866.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
Product Description
804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Manufacturer
Terumo Cardiovascular Systems Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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