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.
Recall
- Recall Number
- Z-0707-06
- Event Number
- 34858
- FEI Number
- 2183870
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 27, 2006
- Posted
- March 18, 2006
- Terminated
- December 26, 2006
- Address
- Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890
Description
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.
Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
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.
GA, OK and TX
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