Devices

Device Recall Maverick 2" Monorail PTCA Catheter

Model / Serial
Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
Product Description
Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-1225 || Use before 2007-01 || UPN H7493892812250 || Sterilized with ethylene oxide gas || Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-2035 || Use before 2007-01 || UPN H7493892820350 || Sterilized with ethylene oxide gas || Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Manufacturer
Boston Scientific Corporation
1 Event
- Recall of Device Recall Maverick 2" Monorail PTCA Catheter

Manufacturer

Boston Scientific Corporation

Manufacturer Address
Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
Source
USFDA

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