notyard
09-04-2008, 08:29 AM
FDA class II recall:
PRODUCT
Smash Balloon Dilatation Catheter- is intended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, tibioperoneal vessels in whose lumens are obstructed by atheroscl****** plaque, Recall # Z-1652-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated April 8, 2008.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON
Since July 2007, Boston Scientific has tracked an increasing trend in complaints regarding cracks and damage to the balloon inflation hub. The potential clinical effects related to these types of cracks and damage could include no inflation, difficulty inflating, slow deflation, partial deflation or, in a worst case scenario, no deflation of the balloon.
VOLUME OF PRODUCT IN COMMERCE
17,891 units
DISTRIBUTION
Internationally
PRODUCT
Smash Balloon Dilatation Catheter- is intended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, tibioperoneal vessels in whose lumens are obstructed by atheroscl****** plaque, Recall # Z-1652-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated April 8, 2008.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON
Since July 2007, Boston Scientific has tracked an increasing trend in complaints regarding cracks and damage to the balloon inflation hub. The potential clinical effects related to these types of cracks and damage could include no inflation, difficulty inflating, slow deflation, partial deflation or, in a worst case scenario, no deflation of the balloon.
VOLUME OF PRODUCT IN COMMERCE
17,891 units
DISTRIBUTION
Internationally