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.
FDA Recall Z-1141-03 · Posted 2003-08-20
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Recalling FirmAbbott Vascular Devices
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-07-21
Date Terminated2003-08-20
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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