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U.S. Department of Health and Human Services

Class 2 Device Recall VENTAK PRIZM AVT

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 Class 2 Device Recall VENTAK PRIZM AVTsee related information
Date Initiated by FirmJune 17, 2005
Date PostedJune 30, 2005
Recall Status1 Terminated 3 on March 02, 2008
Recall NumberZ-0954-05
Recall Event ID 32391
PMA NumberP960040S028 
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
ProductVENTAK 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
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
866-484-3268
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.
FDA Determined
Cause 2		Other
ActionFirm 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 Commerce937 devices (714 currently implanted worldwide)
Distributionworldwide. 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 CycleTPLC 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 DatabasePMAs with Product Code = LWP
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