FDA
BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter;
Catalog #: B3225-10, Lot #: 010586G;
Catalog #: B3225-10, Lot #: 030176G;
Catalog #: B3225-15, Lot #: 010626G;
Catalog #: B3225-18, Lot #: 020246G.
The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
On 7/21/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.