ENDORETURN arterial cannula: is indicated for patients who undergo cardiopulmonary bypass. Its purpose is to deliver oxygenated blood for cardiopulmonary bypass during surgery. The ENDORETURN cannula with hemostasis valve allows catheter introducer: it is indicated for patients that require the introduction of catheters. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. Arterial cannulaDIRECT: and the AUTOINCORTER are indicated for patients who experience cardiopulmonary bypass. The aim of the arterial cannula is to deliver oxygenated blood for cardiopulmonary bypass during surgery. AUTOINCYCOR: the AUTOINCORTER is intended to be used with the HEARTPORT arterial cannula. Its purpose is the incision of the aorta and the introduction of the cannula into the aorta. Arterial cannulaENDORETUM: is indicated for patients who experience a cardiopulmonary derivation. Its purpose is to deliver blood-oxygenated for cardiopulmonary bypass during surgery. The CANORETUM cannula with hemostasis valve allows the hemostatic introduction and removal of the ENDOCLAMP aortic catheter from HEARTPORT.Vain of the catheter introducer: it is indicated for patients requiring the introduction of catheters and the removal of the aortic catheterENDOCLAMP from HEARTPORT. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. DIRECTFLOW arterial cannula: and the autoinclusor are indicated for patients who undergo cardiopulmonary bypass. The aim of the DIRECTFLOW cannula is to deliver oxygenated blood for cardiopulmonary diversion during surgery. The arterial cannula
“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.