The Food & Drug Administration slapped a Class I recall on Cardiovascular Systems Inc.’s recall of its ViperSheath catheter introducer.
St. Paul, Minn.-based CSI (CSI) was the second company forced to issue a voluntary recall of products made by Thomas Medical Products Inc., following a similar action last month by Johnson & Johnson’s (JNJ) Cordis Corp. CSI pulled the ViperSheath products after receiving three reports of stretching or fracture during use. The devices are used to ease catheter insertions into the bloodstream.
The FDA’s Class I recall, its most serious type, means the watchdog agency believes “there is a reasonable probability that use of these products will cause adverse health consequences or death.”
Cordis recalled its Crossover sheath introducers, also made by Thomas Medical, Oct. 27 after receiving 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 in either the Crossover or ViperSheath incidents, although all three of the ViperSheath problems also required surgical intervention to retrieve portions of the sheath.
A representative of Malvern, Pa.-based Thomas Medical, which is owned by GE Healthcare, told MassDevice the company had no comment on the recalls.
Sheath introducers are large-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.
CSI said it already contacted all of its customers about the recall and is arranging for the return of the sheaths. The company also said it notified the U.S. Food and Drug Administration, which will monitor the recall through its MedWatch program.
CSI posted first-quarter sales of $15.2 million for the three months ended Sept. 30, up 30.5 percent compared with $11.6 million during the same period last year, and narrowed its net losses from $13.7 million during the first quarter of fiscal 2009 to $6.2 million during Q1 2010.