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U.S. Department of Health and Human Services

Class 3 Device Recall EASY CORE" COAXIAL KIT 15G X 15CM (BX5)

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  Class 3 Device Recall EASY CORE" COAXIAL KIT 15G X 15CM (BX5) see related information
Date Initiated by Firm October 07, 2008
Date Posted November 28, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-0334-2009
Recall Event ID 50096
510(K)Number K040893  
Product Classification Biopsy Needle Kit - Product Code FCG
Product Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570.

Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
Code Information 11546134 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer Reason
for Recall		 Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.
FDA Determined
Cause 2		 Device Design
Action Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated October 21, 2008. The letter was addressed to The Hospital Field Action Contact. The letter described the problem and products being recalled. The letter stated that it was very important that the attached product table be used carefully and consider both inner and outer packaging product codes when searching for affected/recalled product as the UPN numbers on the inner and outer labeling are different. Requested to discontinue use of product, identify, and segregate and return affected products to BSC. Letter also requested to complete and return the Reply Verification Tracking Form.
Quantity in Commerce 3808 total for all products
Distribution Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR.
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 = FCG and Original Applicant = BOSTON SCIENTIFIC CORP.
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