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U.S. Department of Health and Human Services

Class 2 Device Recall BIOTRONIK INVENTRA

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  Class 2 Device Recall BIOTRONIK INVENTRA see related information
Date Initiated by Firm March 08, 2021
Create Date April 21, 2021
Recall Status1 Terminated 3 on April 25, 2023
Recall Number Z-1460-2021
Recall Event ID 87549
PMA Number P050023S079 
Product Classification Defibrillator, implantable, dual-chamber - Product Code MRM
Product BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Code Information Serial Number 60781273 60782345 60782367 60782368 60782370 60782375 60784295 60795401 60795403 60795407 60795413 60799707 60799709 60799710 60799711 60799712 60799715 60799720 60799721 60799723 60799725 60799726 60799727 60799728 60799729 60799730 60799731 60799732 60799733 60799734 60799737 60799738 60799740 60799742 60799743 60799744 60799746 60799747 60799748 60799750 60799752 60799753 60799754 60799755 60801025 60801026 60801029 60801031 60801032 60801034 60801035 60801036 60801038 60801039 60801041 60801042 60801043 60801044 60808193 60808204 60808205 60808207 60808208 60808210 60809399 60809400 60809402 60809403 60809407 60809408 60809409 60809414 60809415 60810269 60810276 60810278 60810279 60810280 60810281 60810282 60810283 60810284 60810285 60810286 60810287 60810290 60810291 60810293 60810294 60810295 60811776 60811795 60811796 60811797 60811798 60811801 60811803 60811804 60811805 60811807 60811808 60811810 60811812 60816722 60816724 60816725 60816726 60816728 60816729 60816730 60816731 60816732 60816737 60816740 60816741 60816742 60816743 60816744 60816745 60816746 60816747 60816748 60816750 60816751 60828957 60828958 60828959 60828961 60828963 60828966 60828968 60828969 60828971 60828972 60828973 60828974 60828975 60828976 60829112 60829113 60829114 60829115 60829116 60829118 60829119 60829122 60829123 60829124 60829125 60829126 60829128 60829130 60829134 60829136 60829138 60829139 60829140 60829141 60829142 60829143 60829144 60829145 60829146 60829148 60829149 60829151 60829154 60829155 60829156 60829157 60829158 60829159 60829160 60829161 60832097 60832099 60832103 60832104 60832105 60832108 60832109 60832111 60832372 60832373 60832377 60832378 60832382 60832384 60832386 60832387 60832389 60832392 60832394 60832399 60832404 60832406 60832408 60832410 60832412 60832414 60832415 60832418 60832419 60832426 60832427 60832732 60832735 60832736 60832740 60832743 60832745 60832747 60832750 60832751 60832752 60832753 60832766 60832769 60832770 60832771 60832773 60832774 60832776 60832779 60832781 60832782 60832784 60832881 60832882 60832883 60832884 60832885 60832886 60832887 60832888 60832894 60832900 60832901 60832903 60832905 60832906 60832907 60832909 60832911 60832912 60832917 60832924 60832925 60832926 60832927 60832929 60832930 60832931 60832932 60832933 60832934 60832935 60832936 60832938 60832941 60832942 60832943 60832944 60832948 60833379 60833380 60833382 60833383 60833384 60833385 60833388 60834409 60834416 60834419 60834424 60834425 60836070 60837616 60837617 60837618 60839098 60829147 60832737 60837601 60839093  
Recalling Firm/
Manufacturer		 BIOTRONIK Inc
6024 Jean Rd
Lake Oswego OR 97035-5571
For Additional Information Contact BIOTRONIK Technical Services
1800-547-0394
Manufacturer Reason
for Recall		 There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
FDA Determined
Cause 2		 Device Design
Action On 3/8/21, BIOTRONIK issued a "Urgent Field Safety" recall notification to all affected consignees via UPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. To determine if a specific device is affected by this corrective action you can lookup the device at the following web address: www.biotronik.com/devicelookup. 2. Devices in stock: Do not implant any potentially affected devices. Local BIOTRONIK representatives will replace affected devices in hospital inventory. 3. Continue with the standard patient follow-up schedule. -During follow-ups: Verify the status of the device and battery during in-office or Home Monitoring follow-ups. Please note that unresponsive devicesor those that are not transmitting data may be experiencing this issue and your BIOTRONIK representative should be informed if you observe any unusual device behavior. -Home Monitoring should be utilized whenever possible as it provides timely ERI warnings to reduce the risk of sudden loss of therapy. If you do not yet use Home Monitoring, please consider if this option is appropriate for you and your patients. BIOTRONIK will provide Cardio Messenger devices to monitor implants affected by this advisory. If you would like to register for Home Monitoring, please contact your local BIOTRONIK representative. 4. If there is an unexpected ERI notification for a device that is subject to this advisory, a timely replacement should be considered based on the patients underlying conditions: - For patients that are not pacemaker dependent, or patients with a primary prevention ICD, device replacement within one week after ERI notification is recommended. - For pacemaker dependent patients, replacement of the device is recommended immediately after ERI notification. 5. In consultation with our medical advisory board, BIOTRONIK does not recommend prophylactic replacement. The risk of complications for ICD exchange1-3 outweighs
Quantity in Commerce 285 Unit
Distribution US: Nationwide OUS: Worldwide
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.
PMA Database PMAs with Product Code = MRM and Original Applicant = BIOTRONIK, INC.
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