Most Serious Medical Device Recalls of 2015
As of December 28, there were 31 Class I medical device recalls this year. It’s a big improvement over 2014, when the total reached 60. FDA initiates Class I recalls when use of a device can lead to severe or life-threatening injuries, or death. HeartWare topped the list with five Class I recalls, while Teleflex Medical had four, and Boston Scientific, Covidien, and Insulet Corp. tied with two recalls each.
One of the most serious recalls in 2015 involved HeartWare’s Heart Ventricular Assist Device (HVAD). The company initiated five recalls of the device, the first of which occurred in April. Among the problems with the device were maintaining continuous power supply, worn alignment guides, power management software upgrades, discoloration of the outer sheath as well as cracking, and driveline pulling and snagging that can result in disconnection. HeartWare reported three deaths related to use of the HVAD, which is intended to deliver blood from the heart to the body, and at least 37 malfunctions.
The use of Maquet Medical Systems’ Tiger Paw surgical staple, used to close tissue in the left atrial appendage, resulted in one reported death. The device was recalled in late March because it could tear tissue, including the left atrial wall, or cause bleeding. The company reported 51 adverse events in addition to the one death. More than 4000 units were distributed in the United States between April 2013 and March 2015.
Other Class I medical device recalls that resulted in patient deaths this year included a portable oxygen unit, which could ignite and burst (manufactured by Wester/Scott Fetzer Co.); and Boston Scientific’s RotaWire Elite GuideWire and wireClip Torquer Guidewire, components of the Rotablator Rotational Atherectomy System that could reportedly crack and separate from the device.
Baxter Healthcare recalled its VASCU-GUARD peripheral vascular patch, which was distributed to 770 customers (nearly 4000 units) in the United States between March and May of 2015. The patch is used to rebuild peripheral blood vessels, but according to FDA, the company pulled the product because surgeons may have had difficulty distinguishing the smooth side of the patch from the rough side (incorrect implantation of the patch could lead to the formation of blood clots). Baxter reported 51 complaints and one serious injury due to use of the product.
Medtronic’s Shiley tracheostomy tube for neonatal and pediatric populations was recalled after the company received reports that switching the tubes from an older version to a newer version could lead to breathing problems. This issue could be due to the fact that a patient’s airway becomes accustomed to a tube and changing it can cause obstruction of the airway. Medtronic reported 12 serious injuries and no deaths.
CareFusion recalled nearly 6500 Alaris Syringe Pumps following a pump alarm error that could lead to an interruption in infusion therapy. There were 108 reports of the issue (not permanent injury) and no deaths.
A full list of this year’s recalled medical devices is available on FDA’s website.
Related Articles
-
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
-
What’s up with the trend in Class I initiated recalls?
-
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
-
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
-
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an…
