Z-0328-2008

Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol...

Name: Z-0328-2008 Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol...
Creator: Boston Scientific Corp
Published: 2007-07-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-07-19 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corp began a recall of Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710... on 2007-07-19. The reason FDA records is "Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use". 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-0328-2008
Status: Terminated
Initiated: 2007-07-19
Posted: 2007-12-07
Terminated: 2008-02-17
Recalling firm: Boston Scientific Corporation
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
Product code: DYB Introducer, Catheter
Reason for recall: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 249 (199 U.S.A. plus 50 international)
Distribution: Worldwide: USA and The Netherlands.
Product codes and lots: Lot /Batch Number: 9498023.

Product code DYB

K952828Class IIMedi-Tech Percutaneous Introducer SystemBoston Scientific Corp / cleared 1995-08-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)