Z-2479-2011

Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-06127. 6 mm x 120 mm x...

Name: Z-2479-2011 Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-06127. 6 mm x 120 mm x...
Creator: Boston Scientific Corporation
Published: 2011-05-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-05-19 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-06127. 6 mm x 120 mm x 75 cm (stent diameter x stent length x delivery... on 2011-05-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2479-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-06-16
Terminated: 2014-02-04
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-06127. 6 mm x 120 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-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
Product code: NIP Stent, Superficial Femoral Artery
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
Root cause tag: design
FDA 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 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.
Product codes and lots: Lots: 14164683, 14194241, 14212645, 14218066, 14218447, 14229678. 14237239, 14245445, 14245447, 14245451, 14247059.

Product code NIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)