Recall Z-2485-2011 ยท NIP Stent, Superficial Femoral Artery
Boston Scientific Corporation
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-06807. 6 mm x 80 mm x 75 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-exp
| Date | Jun 16, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root 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 Author |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.