Z-0912-06

ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a...

Name: Z-0912-06 ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a...
Creator: Ev3, Inc
Published: 2006-03-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-03-08 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc began a recall of ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice... on 2006-03-08. The reason FDA records is "A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter". 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-0912-06
Status: Terminated
Initiated: 2006-03-08
Posted: 2006-05-31
Terminated: 2007-02-03
Recalling firm: Medtronic, Inc.
Product: ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
Quantity in commerce: 29
Distribution: Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
Product codes and lots: Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864

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)