The FDA has classified the Medtronic's previous action related to the Octopus Nuvo tissue stabilizer, which is used to stabilize tissue during certain surgical procedures, as a Class I recall. The agency classifies a recall as Class I when it believes there is a reasonable probability that use of the recalled product will cause serious adverse health consequences.
Medtronic voluntarily recalled the device from the market Sept. 14 because a component could fracture during use, potentially resulting in fragments falling into the patient's chest cavity and/or damaging the heart tissue. Medtronic has received two reports of device failure occurring during patient use, which required retrieval of device fragments from the surgical wound; neither event resulted in permanent impairment or death, according to a company statement.
"There are no reports of any adverse effects, of any illness or any injury to any patients," says Kathleen Janasz, a Medtronic spokeswoman, according to Minnesota Public Radio. "All of the health care facilities that purchased it have been notified. Health care facilities just need to return the device."