Cordis Corp. is recalling its Crossover sheath introducer after receiving complaints that the device, used to ease catheter insertions into the bloodstream, stretched or fractured during use.
The voluntary recall announced Oct. 27 affects all lots distributed between Aug. 14 and Sept. 23. To date, Cordis said it has received six complaints from Crossover users, with two instances of physicians needing to surgically retrieve portions of the sheath after it broke apart.
No patients were permanently injured due to the possible defect, Cordis added. The Crossover sheath was designed and produced by Thomas Medical Products Inc., a Malvern, Pa.-based contract manufacturer, and distributed by Cordis, the medical device arm of healthcare giant Johnson & Johnson.
Sheath introducers are larger-bore, gradually tapered tubes used to create an entry point into arteries and veins for devices and fluids. The Crossover sheaths are coil-reinforced, which helps prevent kinking during insertion but also increases the potential of punctures downstream if the sheath fractures. Broken pieces also can lodge in blood vessels, restricting normal blood flow or even causing distal ischemia or infarctions.
Cordis said it already contacted all of its customers about the recall and is arranging for the return of Crossover sheaths. The company also said it notified the U.S. Food and Drug Administration, which will monitor the recall through its MedWatch program.
The recall covers lot ranges U0000025 through U0000059 and catalog numbers 403545S, 403585S, 403645S, 403685S, 403745S and 403785S.