Devices

Device Recall VOYAGER NC Coronary Dilatation Catheter

Model / Serial
Part Number: 1011759-08, Lot Numbers: 8050961 and 8062361.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution.
Product Description
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
Manufacturer
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
1 Event
- Recall of Device Recall VOYAGER NC Coronary Dilatation Catheter

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer Address
Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
Source
USFDA

One device with a similar name

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Device Recall VOYAGER NC Coronary Dilatation Catheter

Model / Serial
Part Number: 1011759-12, Lot Numbers: 8041051, 8050561, 8061961 and Part Number: 1011750-12, Lot Number 8100761.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
Manufacturer
Abbott Vascular-Cardiac Therapies dba Guidant 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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