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
In april 2015, heartware, now a part of medtronic, notified users of a safety issue related to the hvad pump driveline splice kit. medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
조치
HeartWare, now a part of Medtronic sent an Urgent Medical Device Recall letter on April 2015 and a follow-up letter on March 2017, to customers via overnight mail and/or email.. The letters identified the affected product, problem and actions to be taken. Customers were instructed to review the recall notice, forward the notice to individuals within their organization who need to be aware of the notice, complete, sign, and return the Acknowledgement Form . For questions contact your local HeartWare representative.
Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
제품 설명
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit || Product Usage: || Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
“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.