U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Ventricular (assisst) bypass - Product Code DSQ
원인
Potential to electrostatic discharged (esd).
조치
HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to quality@heartwareinc.com.
Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service.
For questions regarding this recall call 305-364-1575.
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
제품 설명
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
“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.