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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Constellation Advanced Mapping Catheter

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  Class 2 Device Recall Boston Scientific Constellation Advanced Mapping Catheter see related information
Date Initiated by Firm February 14, 2005
Date Posted March 18, 2005
Recall Status1 Terminated 3 on August 22, 2005
Recall Number Z-0639-05
Recall Event ID 31230
510(K)Number K983171  K992777  K000277  K021232  K003782  
Product Classification Catheter, Intracardiac Mapping, High-Density Array - Product Code MTD
Product Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
Code Information Model numbers 8031, 8038, 8048, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0.   Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
Recalling Firm/
Manufacturer		 Boston Scientific
2710 Orchard Pkwy
San Jose CA 95134-2012
For Additional Information Contact
408-895-3500
Manufacturer Reason
for Recall		 The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
FDA Determined
Cause 2		 Other
Action All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures.
Quantity in Commerce 6694 units were distributed.
Distribution This product was distributed to 521 accounts worldwide.
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.
510(K) Database 510(K)s with Product Code = MTD and Original Applicant = BOSTON SCIENTIFIC CORP.
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