Boston Scientific Corp 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 0011520533 and 0011575888.
Products Sold
Lots 0011520533 and 0011575888.
Boston Scientific Corp is recalling Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Sp due to These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026