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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-0702-03
Recall Event ID 25629
PMA Number P000009/S4 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
Code Information Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077, 78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125,78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652
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 49 devices (45 still implanted)
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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