Class 2 Device Recall BIOTRONIK Iforia

• Date Initiated by Firm: March 08, 2021
• Create Date: April 21, 2021
• Recall Status: Terminated on April 25, 2023
• Recall Number: Z-1448-2021
• Recall Event ID: 87549
• PMA Number: P050023S058
• Product Classification: Defibrillator, implantable, dual-chamber - Product Code MRM
• Product: BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: Serial Number 60717860 60722974 60725417 60725753 60726857 60726883 60726910 60727193 60727205 60727215 60727225 60727234 60727253 60727408 60727417 60728042 60728047 60728050 60728804 60728809 60728810 60728811 60728813 60728825 60728852 60728854 60728857 60728865 60728888 60728913 60728915 60728936 60728989 60728998 60729019 60729022 60729047 60729049 60729051 60729056 60729065 60729068 60729084 60729087 60729120 60729122 60729804 60730307 60730321 60730325 60730333 60730337 60730356 60730599 60730623 60731392 60731401 60731422 60738027 60738986 60740536 60740540 60740542 60740568 60740569 60740599 60740965 60740982 60740988 60741013 60741028 60741031 60741276 60741295 60741307 60741310 60741338 60741623 60741633 60741653 60741734 60741752 60741761 60741781 60741797 60741799 60744245 60744246 60744251 60744252 60744255 60744256 60744258 60744259 60744261 60744285 60744286 60744288 60744289 60744292 60744295 60744296 60744299 60744304 60744307 60744311 60744312 60744313 60744314 60744316 60744321 60744918 60744919 60744921 60744924 60744926 60744930 60744933 60744934 60744937 60744940 60744948 60744953 60744957 60744958 60744959 60744960 60744961 60744964 60744970 60744972 60744974 60744976 60744978 60744979 60744981 60744985 60744988 60744992 60745002 60745003 60745746 60745752 60745753 60745754 60745756 60745757 60745760 60745761 60745763 60745767 60745768 60745769 60745771 60745772 60745773 60745775 60745776 60745778 60745781 60745788 60745790 60745793 60745797 60745799 60745800 60745804 60745810 60745811 60745813 60745814 60745855 60745858 60745868 60745869 60745871 60746822 60746824 60746825 60746827 60746829 60746830 60746831 60746832 60746834 60746836 60746841 60746843 60746845 60746846 60746847 60746848 60746851 60746852 60746854 60746858 60746860 60746863 60746876 60746878 60746881 60747043 60747047 60747049 60747056 60747058 60747075 60747083 60747084 60747085 60747086 60747089 60747092 60747406 60747412 60747429 60747430 60747431 60747432 60747435 60747441 60747442 60747443 60747451 60747457 60747462 60747645 60747652 60747653 60747779 60747788 60747792 60747795 60747803 60747838 60747844 60747851 60747858 60747867 60747871 60747874 60747876 60747878 60748051 60748078 60748083 60748084 60748093 60748359 60748366 60748413 60748414 60748433 60750124 60750126 60750132 60750178 60750256 60750585 60750599 60750601 60750791 60750822 60750850 60750853 60751165 60751171 60753082 60753084 60753990 60753991 60754014 60754015 60754339 60754345 60754349 60755024 60755027 60755028 60755033 60755042 60755045 60755052 60755056 60755057 60755058 60755060 60755061 60755063 60755066 60755071 60755074 60755079 60755080 60755094 60755095 60755264 60755265 60755267 60755268 60755269 60755276 60761059 60761060 60761217 60761885 60761886 60761903 60765643 60766472 60767441 60767475 60767990 60767996 60768009 60768017 60768045 60768178 60768226 60768227 60768236 60768468 60768663 60769159 60769237 60769588 60769608 60769916 60769925 60769936 60769937 60769956 60769965 60769966 60769967 60769970 60770118 60770119 60770120 60770125 60770126 60770129 60770143 60770144 60770179 60770182 60770183 60770201 60770203 60770206 60771282 60771318 60771325 60771451 60771741 60771763 60771849 60773207 60773227 60773286 60773471 60773498 60773874 60773876 60773877 60773880 60773881 60773920 60773925 60773930 60773935 60773936 60773939 60774134 60774145 60774271 60774624 60774742 60775222 60775813 60775830 60776012 60776034 60776041 60776043 60776045 60776048 60776050 60776053 60776068 60776069 60777141 60780791 60781628 60781640 60781671 60782846 60782847 60782868 60783076 60783078 60783084 60783085 60783094 60783098 60783100 60783102 60783109 60783110 60783111 60783112 60783271 60783275 60783278 60783279 60783284 60783285 60783287 60783288 60783297 60783488 60783492 60783501 60783511 60783837 60783842 60783843 60783845 60783863 60783864 60783866 60783879 60783898 60783901 60783903 60784213 60784219 60784221 60784224 60784226 60784227 60784229 60784230 60784231 60784256 60784258 60784263 60784268 60784281 60784496 60784497 60784498 60784499 60784501 60785421 60789050 60789815 60790050 60790054 60790063 60794439 60794815 60800904 60801183 60801224 60801259 60801266 60801373 60801376 60803920 60803930 60803931 60803933 60804440 60804446 60804450 60804452 60805800 60806415 60808384 60808957 60809164 60730301 60741331 60768463 60769917 60770205 60783075 60790070
• 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: 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: 490 units
• 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.