Abbott Vascular Devices 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Vascular Devices
Lot Codes / Batch Numbers
Catalog #: B3225-10, Lot #: 010586G, Catalog #: B3225-10, Lot #: 030176G, Catalog #: B3225-15, Lot #: 010626G, Catalog #: B3225-18, Lot #: 020246G.
Products Sold
Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.
Abbott Vascular Devices is recalling BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 01 due to The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026