Date Initiated by Firm |
June 16, 2005 |
Date Posted |
August 03, 2005 |
Recall Status1 |
Terminated 3 on November 17, 2005 |
Recall Number |
Z-1065-05 |
Recall Event ID |
32495 |
PMA Number |
P010012S008 |
Product Classification |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
|
Product |
CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies. |
Code Information |
508822, 508827 and 508862 |
Recalling Firm/ Manufacturer |
Guidant Corporation 4100 Hamline Ave N Saint Paul MN 55112-5700
|
Manufacturer Reason for Recall |
Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
|
FDA Determined Cause 2 |
Other |
Action |
Sales Representatives notified 06/16/05 to return devices in their area. |
Quantity in Commerce |
3 |
Distribution |
CA, IL, MI, MO, OR and PA |
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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