“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
Description du dispositif
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) || The product is used during ablation surgical procedures.
Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.
Description du dispositif
Recalled product is a component of the Newport Medical Instruments e360 || Ventilator: single board computer, part number SBC2105A. || Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
Nationwide Distribution (USA) including the states of: AZ, CA, CO, FL, GA, IL, KY, KS, LA, MA, MO, MS, NC, NM, NY, OH, PA, SD, TN, TX, UT, VA, WA, WI, WV and WY.
Description du dispositif
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. || Product Usage: || To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X. Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. || Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
Description du dispositif
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 || The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.