Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, Sterilized with ethylene oxide gas. UPN for inner pouch M001434580. 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.
FDA Recall Z-0335-2009 · Posted 2008-11-28
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFCG
Date Initiated2008-10-07
Date Terminated2011-12-10
Product Quantity3808 total for all products
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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