Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
FDA Recall Z-1618-2008 · Posted 2008-08-30
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDRF
Date Initiated2008-02-14
Date Terminated2011-01-08
Product Quantity827 units total
Reason for Recall
Package sterile barrier may be breached, compromising sterility.
Firm Action
Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form.
If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.