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U.S. Department of Health and Human Services

Class 2 Device Recall Heartstring II Proximal Seal aortic cutter

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  Class 2 Device Recall Heartstring II Proximal Seal aortic cutter see related information
Date Initiated by Firm July 05, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on January 09, 2006
Recall Number Z-1396-05
Recall Event ID 32573
Product Classification Introducer, Catheter - Product Code DYB
Product Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Code Information HSK-2038, HSK-2043. All lots are affected by this recall.
Recalling Firm/
Manufacturer		 Guidant Cardiac Surgery
3200 Lakeside Dr
Santa Clara CA 95054-2807
Manufacturer Reason
for Recall		 Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
FDA Determined
Cause 2		 Other
Action Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented.
Quantity in Commerce 7391 units
Distribution Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.
Total Product Life Cycle TPLC 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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