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Teleflex recently announced that the FDA has labeled the global recall of more than 47,000 Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits as a Class I corrective action. The Arrow® IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.
The Class I tag is reserved for situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The scenario clearly meets that definition, for Teleflex said separation of the devices’ sheath body from the sheath hub had resulted in 6 serious injuries and one death at the time of the February recall. Consequences of the mechanical failure include significant blood loss and loss of treatment, according to a release.
Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex. The release contains the affected product codes, as does the February field safety notice to medical staff and product distributors. Customers are urged to quarantine the recalled devices and contact Teleflex to arrange for their return.
According to Hong Kong’s governmental Department of Health, the percutaneous insertion kit contains a sheath introducer, which is used by some clinicians during the implantation procedure. The recall pertains to the introducer, but does not affect other items in the insertion kit. Sheaths with an 8 French diameter made by St. Jude Medical, Terumo and Cardinal Health’s Cordis can be used for installation of the Arrow intra-aortic balloon catheters if needed.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
For Further Information
More on the markets for peripheral vascular devices in the US can be found in the latest report suite published by iData entitled US Peripheral Vascular Device Market Report Suite – 2016, which covers the US as well as the following markets: peripheral vascular stents, PTA balloon catheters, atherectomy devices, chronic total occlusion devices, embolic protection devices, stent-grafts, surgical grafts, AV access thrombectomy devices, inferior vena cava filters, diagnostic and interventional catheters, standard and hydrophilic guidewires, introducer sheaths, vascular closure devices, and transcatheter embolization devices.
The iData series on the market for peripheral vascular devices also covers China, India, Japan, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a US Peripheral Vascular Device Market – 2016 report brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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