Z-0707-06

ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3...

Name: Z-0707-06 ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3...
Creator: Ev3, Inc
Published: 2006-02-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-02-27 / Terminated / root cause: packaging

FDA source

Ev3, Inc began a recall of ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA... on 2006-02-27. The reason FDA records is "Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected". 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-0707-06
Status: Terminated
Initiated: 2006-02-27
Posted: 2006-03-18
Terminated: 2006-12-26
Recalling firm: Medtronic, Inc.
Product: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
Root cause tag: packaging
FDA root cause: Other
Action: An ev3 field representative will notify affected consignees in person beginning 2/27/2006. Product retrieval or use of the device will be documented using on a ''Field Action Form''. Account credit or product from an unaffected lot number will be provided.
Quantity in commerce: 4
Distribution: GA, OK and TX
Product codes and lots: Lot 1211723, expiration date Nov 2007

Product code FGE

K011806Class IIProtege Self-Expanding Nitinol Stent with Starport Delivery TechnologySulzer Intratherapeutics, Inc. / cleared 2001-09-07

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)