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.
St. jude medical is performing a voluntary recall of batch 4671318, model number 401353 of the response fixed curve deca 6f 65cm csl 2/8 catheter. specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (supreme fc quad 5f catheter) within the packaging. to date, no serious injuries have occurred as a result of this issue.
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St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
“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.