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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 21, 2003
Date Posted April 01, 2003
Recall Status1 Terminated 3 on September 08, 2003
Recall Number Z-0701-03
Recall Event ID 25629
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Deikos A+ Implantable Cardioverter Defibrillator
Code Information Model No. 334 341 Serial Nos. 78062821, 78062822, 78062831, 78062838, 78062839, 78062901, 78062957
Recalling Firm/
Manufacturer		 Biotronik Inc
6024 Jean Road
Lake Oswego OR 97035-5369
For Additional Information Contact Jon Brumbaugh
888-345-0374
Manufacturer Reason
for Recall		 Potential for battery to delivery less than full amount of energy
FDA Determined
Cause 2		 Other
Action The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.
Quantity in Commerce 7 devices
Distribution The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
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.
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