Z-0442-06

Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model...

Name: Z-0442-06 Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model...
Creator: Ev3, Inc
Published: 2005-08-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-08-01 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc began a recall of Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75 on 2005-08-01. The reason FDA records is "A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0442-06
Status: Terminated
Initiated: 2005-08-01
Posted: 2006-01-25
Terminated: 2006-12-31
Recalling firm: Medtronic, Inc.
Product: Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
Quantity in commerce: 18 devices
Distribution: AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
Product codes and lots: Lot no. 923291, 923290

Product code FGE

K043243Class IIPrimus Stent and Delivery SystemEv3, Inc. / cleared 2004-12-09

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)