notyard
09-04-2008, 09:47 AM
FDA class II recall:
PRODUCT
Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194, Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, Recall # Z-2165-2008
CODE
Lot 9565194, Exp April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated May 11, 2007.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Internationally
PRODUCT
Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194, Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, Recall # Z-2165-2008
CODE
Lot 9565194, Exp April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated May 11, 2007.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Internationally