Z-1340-04

WALLSTENT Endoprostheses with UNISTEP Plus Delivery System

Name: Z-1340-04 WALLSTENT Endoprostheses with UNISTEP Plus Delivery System
Creator: Boston Scientific Scimed
Published: 2004-07-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-07-09 / Terminated / root cause: packaging

FDA source

Boston Scientific Scimed began a recall of WALLSTENT Endoprostheses with UNISTEP Plus Delivery System on 2004-07-09. The reason FDA records is "Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1340-04
Status: Terminated
Initiated: 2004-07-09
Posted: 2004-08-13
Terminated: 2007-01-05
Recalling firm: Boston Scientific Corporation
Product: WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
Product code: JCT Prosthesis, Tracheal, Expandable
Reason for recall: Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
Root cause tag: packaging
FDA root cause: Other
Action: Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
Quantity in commerce: 82 units (H965402100) aa7 units (H965402100)
Distribution: Inside the US only.
Product codes and lots: 6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023

Product code JCT

K992510Class IIWallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Corp / cleared 1999-11-18

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)