Date Initiated by Firm |
October 04, 2017 |
Create Date |
November 08, 2017 |
Recall Status1 |
Terminated 3 on October 15, 2019 |
Recall Number |
Z-0079-2018 |
Recall Event ID |
78323 |
PMA Number |
P960040 P010012 |
Product Classification |
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
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Product |
VIGILANT X4 CRT-D, Model G247, Sterile.
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
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Code Information |
Serial numbers 174170, 174349, 174598, and 174606. |
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
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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 |
4 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
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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.
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PMA Database |
PMAs with Product Code = NIK and Original Applicant = Boston Scientific Corp.
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