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
Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
원인
This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. if this occurs, treatment may be delayed or interrupted. the firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health c.
조치
The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.