Date Initiated by Firm |
October 04, 2017 |
Create Date |
November 08, 2017 |
Recall Status1 |
Terminated 3 on October 15, 2019 |
Recall Number |
Z-0078-2018 |
Recall Event ID |
78323 |
PMA Number |
P960040 |
Product Classification |
Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
|
Product |
RESONATE EL ICD DR, Model D433, Sterile.
|
Code Information |
Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767. |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 4100 Hamline Ave N Saint Paul MN 55112-5700
|
For Additional Information Contact |
United States Technical Services 800-227-3422
|
Manufacturer Reason for Recall |
The devices have an incorrect firmware configuration.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative. |
Quantity in Commerce |
12 devices |
Distribution |
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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