Boston Scientific Corp Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lot /Batch Number: 9498023.
Products Sold
Lot /Batch Number: 9498023.
Boston Scientific Corp is recalling Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch due to Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
Recommended Action
Per FDA guidance
Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.
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