Z-1141-03

BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G...

Name: Z-1141-03 BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G...
Creator: Abbott Vascular Devices
Published: 2003-07-21
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2003-07-21 / Terminated / root cause: labeling and UDI

FDA source

Abbott Vascular Devices began a recall of BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #... on 2003-07-21. The reason FDA records is "The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1141-03
Status: Terminated
Initiated: 2003-07-21
Posted: 2003-08-20
Terminated: 2003-08-20
Recalling firm: Abbott Vascular
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.
Product code: MAF Stent, Coronary
Reason for recall: The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Distribution: Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.
Product codes and lots: Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

Product code MAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)