A device used in heart surgeries is being recalled by the Food and Drug Administration (FDA) because there is the potential for the device to fracture during use. If this happens, fragments of the device could fall into the patient’s chest cavity and/or damage the heart tissue. The manufacturer has received two reports of device failure during use that required retrieval of the device fragments from the surgical wound. This recall is classified as a Class 1, which is the most serious type of recall issued by the FDA and involves situations in which there is a reasonable probability that use of the product will result in serious health consequences or death.
The recall involves 571 Octopus Nuvo Tissue Stabilizers manufactured by Medtronic, Inc. The devices were distributed to healthcare facilities in the U.S., Canada, and Europe. Healthcare facilities with the devices should discontinue use immediately and return all unused Octopus Nuvo Tissue Stabilizer devices to Medtronic. Patients need not take action, as any problems with the device would have happened during surgery.
Physicians and healthcare facilities can direct questions to their Medtronic representative or contact the CardioVascular Lifeline for technical services, Monday through Friday during business hours, at 1‐877‐526‐7890. Any adverse reactions experienced with the use of this product, and/or quality problems also should be reported to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch.