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U.S. Department of Health and Human Services

Class 2 Device Recall Deikos

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  Class 2 Device Recall Deikos see related information
Date Initiated by Firm April 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 21, 2006
Recall Number Z-0944-04
Recall Event ID 28982
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Deikos A+
Code Information Model Number 334 341 Serial numbers: 78062958, 78062960, 78062961, 78062962, 78062997, 78063002
Recalling Firm/
Manufacturer		 Biotronik Inc
6024 Jean Rd
Lake Oswego OR 97035-5308
For Additional Information Contact Jon Brumbaugh
888-345-0374
Manufacturer Reason
for Recall		 Potential for device to not deliver full amount of energy
FDA Determined
Cause 2		 Other
Action On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.
Quantity in Commerce 6
Distribution Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
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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