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Class 2 Device Recall |
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Date Initiated by Firm |
March 21, 2003 |
Date Posted |
May 14, 2003 |
Recall Status1 |
Terminated 3 on October 13, 2004 |
Recall Number |
Z-0817-03 |
Recall Event ID |
26041 |
PMA Number |
P980023/S8 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product |
Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator.
The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.
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Code Information |
Part number 331135. Serial numbers 78140020, 78140021, 78140026, 78140027, 78140029, 78140035, 78140037, 78140038, 78140039, 78140045, 78140046, 78140048, 78140049, 78140051, 78140052, 78140053, 78140054, 78140055, 78140056, 78140057, 78140058, 78140059, 78140060, 78140061, 78140062, 78140063, 78140064, 78140065, 78140066, 78140067, 78140070, 78140071, 78140072, 78140073, 78140102, 78140103, 78140104, 78140105, 78140109, 78140111, 78140112, 78140113, 78140114, 78140124, 78140132, 78140134, 78140135, 78140136, 78140139 |
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 extended charge time anomalies
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FDA Determined Cause 2 |
Other |
Action |
The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients. |
Quantity in Commerce |
49 |
Distribution |
The firm distributed to physicians throughout the United States.
The firm only distributes to US customers. |
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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PMA Database |
PMAs with Product Code = LWS and Original Applicant = BIOTRONIK, INC.
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