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
Temporary Carotid Catheter for Embolic Capture - Product Code NTE
원인
The recall was initiated because abbot vascular has discovered that the identified lots of the rx accunet embolic protection system may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
조치
Abbott Vascular sent an "URGENT DEVICE RECALL" letter dated November 30, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to work with their local account representative to review their inventory, complete the attached Field Action Reconciliation/ Effectiveness Check Form and return any unused identified products to Abbott Vascular.
Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
제품 설명
Brand Name: RX Accunet Embolic Protection System || Common Name: RX Accunet EPS. || Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. || The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.