WATCHMAN FLX / WS5020, WS5024, WS5027, WS5031 and WS5035, specific batches.
Description du dispositif
The closure technology of the left atrial appendage WATCHMAN was designed to avoid embolization of the atrial appendage of the left atrial appendage and reduce the risk of life-threatening hemorrhage in nonvalvular atrial confibrillation patients who are suitable for anticoagulant treatment or who present a contraindication for anticoagulant treatment. of instructions for use: reinforcing the existing instructions for use to offer greater guidance regarding the correct use of the hemostasis valve to avoid coiling and to securely seal the valve. Minimizing the possibility of undesirable blood leakage, which could prevent potentially adverse events from occurring. the patient.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”