Z-0491-2009

Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN...

Name: Z-0491-2009 Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN...
Creator: Boston Scientific Corp
Published: 2008-10-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-10-17 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081. For... on 2008-10-17. The reason FDA records is "These devices may experience difficulty cocking and arming, resulting in an inability to use the devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0491-2009
Status: Terminated
Initiated: 2008-10-17
Posted: 2009-01-12
Terminated: 2009-12-15
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081. For use to endoscopically or percutaneously retrieve tissue samples 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: These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.
Quantity in commerce: 14,254 of all devices.
Distribution: Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
Product codes and lots: Lots 0011520533 and 0011575888.

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)