Class 1 Device Recall Innova SelfExpanding Stent System

• Date Initiated by Firm: May 19, 2011
• Date Posted: June 16, 2011
• Recall Status: Terminated on February 04, 2014
• Recall Number: Z-2522-2011
• Recall Event ID: 58910
• Product Classification: Stent, superficial femoral artery - Product Code NIP
• Product: Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-06803. 6 mm x 80 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall.; The Innova Self-Expanding Stent is available in a variety of diameters and lengths.; The delivery system is also offered in two working lengths (75 cm and 130 cm).; The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions
• Code Information: Lots: 14166909, 14243465, 14256372, 14256374, 14286202, 14293322, 14307654, 14319668.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Brent Hathcock; 763-494-7971
• Manufacturer Reason for Recall: Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d
• FDA Determined Cause: Device Design
• Action: Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.