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Class 2 Device Recall VENTAK PRIZM AVT |
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Date Initiated by Firm |
June 17, 2005 |
Date Posted |
June 30, 2005 |
Recall Status1 |
Terminated 3 on March 02, 2008 |
Recall Number |
Z-0954-05 |
Recall Event ID |
32391 |
PMA Number |
P960040S028 |
Product Classification |
Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
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Product |
VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. |
Code Information |
all serial numbers |
Recalling Firm/ Manufacturer |
Boston Scientific CRM Corp 4100 Hamline Ave N Saint Paul MN 55112-5700
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For Additional Information Contact |
866-484-3268
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Manufacturer Reason for Recall |
The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
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FDA Determined Cause 2 |
Other |
Action |
Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm. |
Quantity in Commerce |
937 devices (714 currently implanted worldwide) |
Distribution |
worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom. |
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 = LWP and Original Applicant = BOSTON SCIENTIFIC
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