Z-0329-2009

Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with...

Name: Z-0329-2009 Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with...
Creator: Boston Scientific Corporation
Published: 2008-10-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-10-07 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide gas . UPN for inner pouch M001434500... on 2008-10-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0329-2009
Status: Terminated
Initiated: 2008-10-07
Posted: 2008-11-28
Terminated: 2011-12-10
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide gas . UPN for inner pouch M001434500 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.
Product code: FCG Biopsy Needle
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 11524375 and 11535831

Product code FCG

K040893Class IIEasy Core Biopsy SystemBoston Scientific Corp / cleared 2004-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)