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Class 2 Device Recall |
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Date Initiated by Firm |
February 21, 2003 |
Date Posted |
April 01, 2003 |
Recall Status1 |
Terminated 3 on September 08, 2003 |
Recall Number |
Z-0700-03 |
Recall Event ID |
25629 |
PMA Number |
P000009 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product |
Tachos DR - Implantable Cardioverter Defibrillator. |
Code Information |
Model No. 355 572 Serial Nos. 78011361, 78011362, 78011364, 78011365, 78011376, 78011378-78011385, 78011389-78011414, 78011416-78011424, 78011426-78011430, 78011432-78011464, 78011466-78011491, 78011493-78011499, 78011600-78011617, 78011619, 78011621-78011639, 78011641, 78011643, 78011647-78011654, 78011656-78011660, 78011684-78011686, 78011689, 78011691, 78011692, 78011699-78011701, 78011704-78011708, 78011713, 78011720-78011723, 78011730-78011743, 78011745-78011758, 78011764-78011768, 78011779 |
Recalling Firm/ Manufacturer |
Biotronik Inc 6024 Jean Road Lake Oswego OR 97035-5369
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For Additional Information Contact |
Jon Brumbaugh 888-345-0374
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Manufacturer Reason for Recall |
Potential for battery to delivery less than full amount of energy.
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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 |
240 (225 still implanted) |
Distribution |
The firm distributed devices to doctors located throughout the U.S.
There is no international distribution from this firm.
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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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