Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The devices are being recalled due to the risk of the sheath body detaching from its hub, after 13 adverse event reports including 6 serious injuries and 1 death.
If the sheath body separates from the sheath hub during insertion, the patient may experience significant bleeding and the interruption of the inflating-deflating balloon therapy.
The FDA updated numbers for the recall as well, which affects 13,405 units distributed nation wide. In an earlier announcement form Teleflex, nearly 50,000 units were said to be affected by the recall.
A total of 10 device models, manufactured between December 1, 2013 and December 1, 2015 and distributed between January 1, 2014 and February 1, 2016, are being recalled.
The company instructed any customers with the devices to quarantine unused items, communicate the recall details and return affected products.