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
pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
원인
Pump may separate at the motor housing while device is explanted.
조치
ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used.
If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com.
Impella 5.0 Circulatory Support System || Catalog number: 004840 || The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours