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 predete Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 predete
Lot Codes / Batch Numbers
Lot 1211723, expiration date Nov 2007
Products Sold
Lot 1211723, expiration date Nov 2007
A medical device manufacturer is recalling ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Ga due to Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, OK, TX
Page updated: Jan 10, 2026