Octopus Nuvo Tissue Stabilizer: Class I Recall - Potential for Device Fracture
AUDIENCE: Risk Manager, Surgery
ISSUE: Medtronic informed healthcare professionals of a recall of the Octopus Nuvo Tissue Stabilizer due to the potential that a component of the device could fracture during use. The resulting potential hazards are that fragments of the component could fall into the patient’s chest cavity and/or 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.
BACKGROUND: All Octopus Nuvo Tissue Stabilizer devices are affected; no other models in the Octopus family of products are affected by this recall.
RECOMMENDATION: Healthcare facilities should immediately discontinue use of the device and return all unused Octopus Nuvo Tissue Stabilizer devices to Medtronic. No action is required of patients, as any adverse event related to the disposable device would have occurred at the time of surgery. Physicians and healthcare facilities can direct questions to their Medtronic representative.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178