EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.Manufactured by St Jude Medical.
St Jude Medical UK Ltd
Technical Services
0046 8 474 4147orSean Hogarth
St Jude Medical UK Ltd
Capulet House
Stratford Business and Technology Park
Stratford-upon-Avon, CV37 7GX
Tel: 01789 207 600
Fax: 01789 207 601Email: shogarth@sjm.com
“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.