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U.S. Department of Health and Human Services

Class 2 Device Recall BIOTRONIK ITREVIA

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  Class 2 Device Recall BIOTRONIK ITREVIA 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-1450-2021
Recall Event ID 87549
PMA Number P050023S079 
Product Classification Defibrillator, implantable, dual-chamber - Product Code MRM
Product BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Code Information Serial Number 60819309 60819312 60819314 60819316 60819317 60819332 60819333 60819614 60819616 60819636 60819638 60819640 60819642 60819643 60819646 60819649 60819652 60819655 60819667 60819682 60819948 60819949 60819954 60819955 60819957 60819964 60819966 60819967 60820682 60820684 60820687 60820690 60820701 60820702 60820704 60820705 60820708 60820709 60820716 60820717 60820720 60820724 60820725 60820726 60821168 60821170 60821171 60821174 60821183 60821184 60821185 60821191 60821193 60821199 60821206 60821207 60821209 60821212 60822252 60822253 60822255 60822256 60822257 60822259 60822262 60822264 60822267 60822269 60822270 60822273 60822278 60822279 60822281 60822543 60822548 60823564 60823569 60823571 60823575 60823576 60823578 60823580 60823602 60823603 60823605 60823607 60823608 60823611 60823612 60823615 60823616 60823618 60823619 60823623 60823629 60823633 60823636 60823641 60823642 60823643 60823647 60823649 60823650 60823653 60823655 60823656 60823658 60823861 60823864 60823865 60823869 60824283 60824484 60824487 60824489 60824498 60824499 60824501 60824504 60824508 60824519 60824521 60824523 60824524 60824527 60824529 60824532 60824534 60824537 60824539 60824676 60824685 60825001 60825008 60825026 60825039 60825044 60825050 60825054 60825058 60825060 60825692 60825702 60825704 60825713 60825720 60825721 60825724 60825905 60825910 60825917 60825925 60825932 60825933 60825936 60825939 60825940 60826485 60826488 60826503 60826505 60826665 60826669 60826711 60826712 60826890 60827427 60827432 60827438 60827439 60827444 60827445 60827716 60827722 60827726 60827728 60827736 60827743 60827752 60827753 60827758 60827759 60827760 60827879 60827894 60827898 60827900 60827907 60827933 60827934 60827935 60827937 60827940 60827945 60827946 60827947 60827948 60827955 60827960 60827964 60828116 60828130 60828139 60828145 60828159 60828172 60831807 60831814 60831869 60831870 60831885 60831911 60831930 60831938 60831940 60832195 60832197 60832207 60833126 60833698 60834129 60834130 60834239 60834261 60834449 60834469 60834473 60834493 60834498 60834509 60834831 60834848 60834854 60834863 60835648 60835656 60836213 60836230 60836231 60836232 60836236 60836237 60837159 60837160 60837162 60837163 60837165 60837168 60837179 60837182 60837195 60837212 60837215 60837216 60837224 60837356 60837359 60837397 60837408 60837412 60837416 60837846 60837849 60838204 60838454 60838464 60838466 60838473 60838485 60838500 60838757 60838758 60838761 60838778 60838849 60838851 60840016 60840026 60840028 60840036 60840052 60840363 60840461 60840468 60840561 60840583 60840602 60840604 60840612 60840620 60840828 60840845 60840851 60840857 60840931 60840945 60840959 60840961 60841094 60841095 60841097 60841112 60841124 60841130 60841442 60841447 60841448 60842352 60842493 60842551 60842569 60842574 60843504 60843807 60843833 60843837 60843915 60843928 60843934 60843946 60856015 60856018 60899176 60907673 60907697 60908108 60912162 60912165 60912169 60912175 60912185 60912196 60912206 60912216 60912231 60912237 60912240 60912552 60912576 60913547 60913818 60922058 60922076 60922077 60922078 60922483 60926965 60927000 60928283 60928286 60928288 60930101 60930925 60930945 60931455 60819647 60820714 60821167 60822263 60822271 60823617 60823853 60824522 60824526 60824627 60824689 60825018 60825942 60826484 60826495 60827757 60827902 60834142 60837183 60839392 60840033 60856013 60856017 60901872 60912562 60915006 60922064 60925883 60928242 60928492 60930126  
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 386 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.
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