Medtronic Inc., Fridley, said Friday the Food and Drug Administration has classified the company's previous action related to the Octopus Nuvo Tissue Stabilizer as a Class I recall. FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
On Sept. 14, Medtronic recalled the device from the market due to the potential that a component of the device could fracture during use, causing a part of it to fall into a patient's chest cavity and damage 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.
Health care facilities should discontinue use of the device and return all unused Octopus Nuvo Tissue Stabilizer devices to the company. No action is required of patients, since any issue related to the disposable device would have occurred at the time of surgery.
All Octopus Nuvo Tissue Stabilizer devices are affected; no other models in the Octopus family of products are affected by this recall. Medtronic said 571 devices have been distributed to health care facilities in the U.S., Europe and Canada.
All affected health care facilities have been notified, and Medtronic is working with them to retrieve all remaining devices.DEBT AND EQUITIES
EnteroMedics Inc., Roseville, held a special shareholders' meeting Friday where several proposals were approved, including an amendment to the company's 2003 Stock Incentive Plan increasing the number of shares authorized under the plan to 2.3 million, and another amendment allowing for a one-time stock option exchange program. EnteroMedics is developing a device to combat obesity.
HickoryTech Corp., Mankato, declared a quarterly dividend of 13.5 cents per share, an increase from 13 cents, payable Dec. 5 to shareholders of record on Nov. 15.
Regis Corp., Edina, declared a regular quarterly dividend of 4 cent per share, payable Nov. 25 to shareholders of record on Nov. 11. The company has about 57.6 million shares outstanding.