FDA classifies Medtronic recall as critical typeby Martin Moylan, Minnesota Public Radio
St. Paul, Minn. — The U.S. Food and Drug Administration has classified Medtronic's previous action to pull a surgical device from the market as a Class I recall, the most serious type of recall.
In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.
The tissue stabilizer being recalled holds tissue in place for surgeons. Last month, Medtronic voluntarily took the Octopus Nuvo tissue stabilizer off the market because a part could break during use and fragments could fall into a patient's chest cavity and damage heart tissue.
"There are no reports of any adverse effects, of any illness or any injury to any patients," said Kathleen Janasz, a Medtronic spokeswoman. "All of the health care facilities that purchased it have been notified. Health care facilities just need to return the device."
Medtronic has received two reports of the device failing. Both required retrieval of device fragments from a surgical wound. The company says neither patient was injured.