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U.S. Department of Health and Human Services

Class 2 Device Recall BiodivYsio

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 Class 2 Device Recall BiodivYsiosee related information
Date Initiated by FirmJuly 21, 2003
Date PostedAugust 20, 2003
Recall Status1 Terminated 3 on August 20, 2003
Recall NumberZ-1141-03
Recall Event ID 26854
Product Classification Stent, Coronary - Product Code MAF
ProductBiodivYsio 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.
Code Information Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G. 
FEI Number 3000718335
Recalling Firm/
Manufacturer		 Abbott Vascular Devices
400 Saginaw Drive
Redwood City CA 94063
For Additional Information ContactDenise Singleton, JD, RAC
650-474-3193
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionOn 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.
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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