Medtronic Octopus Nuvo Recall: Surgical Device May Fracture
A recall has been issued by Medtronic, Inc. for their Octopus Nuvo Tissue Stabilizers, after two reported incidents where the medical devices fractured during heart surgery and dropped debris into the patient’s body.
The FDA classified the Medtronic Octopus Nuvo recall as a Class 1 medical device recall on October 29, meaning that the agency believes the problem could very likely cause severe injury or death.
Medtronic pulled the device from the market on September 14 after receiving the reports where the surgical device fractured and fragments had to be retrieved from surgical wounds. Neither case resulted in permanent injury or death, the company reported.
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The Octopus Nuvo Tissue Stabilizer is used to physically stabilize the heart and minimize motion in selected areas of the heart during heart surgery. The device is disposable and discarded after use. A part of the device, called the collet, can fracture, releasing fragments into the patient’s chest cavity during the surgery, which could damage the heart or cause other complications.
The Octopus Nuvo Tissue Stabilizer recall affects all 571 of the devices that have been distributed to healthcare facilities in the Unted States, Europe and Canada. All of the affected devices have a model number of TSMICS1.
The FDA and Medtronic recommend that healthcare facilities immediately discontinue use and return the recalled devices to Medtronic. A recall letter (pdf) was sent out in September to all known customers and Medtronic is in the process of retrieving all of the remaining devices.
The company recommends that surgeons use the Octopus NS, Octopus Evolution with retractor adaptor, or the Octopus Evolution AS with retractor adapter until such a time as the Octopus Nuvo is re-released.
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