Stent, Iliac

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-04-03Open, ClassifiedEmployee error

  Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

  product mix-up; Vascular stent labeled as one size but contains a different size.

• 2025-04-03Open, ClassifiedEmployee error

  Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

  product mix-up; Vascular stent labeled as one size but contains a different size.

• 2016-01-22TerminatedDevice Design

  Zilver 518RX Vascular Stent with Rapid Exchange Delivery System

  Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event

• 2012-09-01TerminatedPackaging process control

  Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

  Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35

• 2012-02-15TerminatedPackaging

  S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T. CONTROL in the logo/description. All unexpired lots from 15112447 through 15525516.

  Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches.

• 2008-07-31TerminatedMixed-up of materials/components

  CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.

  Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel

• Open, ClassifiedUnder Investigation by firm

  S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The stent is equipped with 12 tantalum markers, 6 at each end, to increase the visibility of the stent under fluoroscopic imaging. The SMART Control stent system is designed to be delivered through an appropriately sized catheter sheath introducer.

  Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".