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.
Hazard
The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
What You Should Do
Remedy
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.
Affected by this recall?
Get a free legal consultation about this recall.
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Products
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
- Brand
- Abbott Vascular Devices
- UPC
- Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.