Z-0122-2008

Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number...

Name: Z-0122-2008 Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number...
Creator: Boston Scientific Target
Published: 2007-06-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-06-14 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Target began a recall of Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538 on 2007-06-14. The reason FDA records is "Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12". 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-0122-2008
Status: Terminated
Initiated: 2007-06-14
Posted: 2007-12-05
Terminated: 2007-12-21
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
Product code: DQX Wire, Guide, Catheter
Reason for recall: Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.
Quantity in commerce: 40
Distribution: Nationwide.
Product codes and lots: Lot Number: 9264947.

Product code DQX

K931584Class IIScimed Transport Steerable Guide Wire and Access.Scimed / cleared 1993-07-01

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)