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U.S. Department of Health and Human Services

Class 2 Device Recall BIOTRONIK ILESTO 7 VRT

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  Class 2 Device Recall BIOTRONIK ILESTO 7 VRT 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-1444-2021
Recall Event ID 87549
PMA Number P050023S076 
Product Classification Defibrillator, implantable, dual-chamber - Product Code MRM
Product BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Code Information Serial Number 60757356 60760363 60760397 60761628 60761631 60761650 60761661 60761664 60762689 60762696 60762706 60762707 60762720 60762723 60762729 60762730 60762915 60764027 60764028 60764030 60764031 60764034 60764037 60764038 60764039 60764041 60764042 60764045 60764047 60764049 60764052 60764054 60764179 60764180 60764181 60764183 60765959 60765960 60765962 60765968 60765969 60765972 60765975 60765978 60765980 60765982 60765983 60765985 60765988 60765989 60765990 60765991 60765993 60765996 60767208 60767210 60767212 60767213 60767214 60767217 60768800 60768806 60769428 60769437 60769448 60769449 60769450 60769452 60773007 60774350 60774360 60774363 60774370 60774413 60775554 60775556 60775557 60775561 60775562 60775563 60775564 60775567 60775569 60775574 60775577 60775578 60775579 60775582 60775587 60775590 60775591 60775592 60775594 60775595 60775597 60775601 60775603 60775875 60775876 60775878 60775882 60775884 60775885 60775886 60775890 60775892 60775893 60775894 60775896 60775898 60775900 60775901 60775902 60775903 60775908 60775910 60775915 60775916 60775918 60775919 60775920 60775924 60775926 60775928 60775930 60775931 60775937 60775938 60775941 60775942 60777214 60777216 60777218 60777219 60777220 60777221 60777223 60777224 60777225 60777227 60777230 60777231 60777233 60777478 60777493 60784111 60785915 60785916 60785920 60785921 60785922 60785924 60785925 60785926 60785927 60785928 60785929 60785930 60785931 60785933 60785934 60785935 60785937 60785939 60785940 60785944 60785947 60785949 60785952 60786165 60786166 60786167 60786168 60786170 60786171 60786172 60786174 60786177 60786178 60786180 60786181 60786182 60786183 60786185 60786188 60786189 60786192 60786193 60786194 60787029 60787032 60787218 60787928 60790686 60790687 60790688 60790689 60790695 60791266 60791268 60791269 60791278 60791280 60791281 60791282 60791283 60791284 60793611 60793612 60793616 60793617 60794005 60794015 60794018 60794021 60794023 60794028 60794032 60794040 60794281 60794287 60794294 60794296 60794297 60794298 60794304 60796187 60799592 60799594 60799597 60799598 60799599 60799601 60799602 60799603 60799604 60799605 60799609 60799610 60799611 60799613 60799614 60799617 60799618 60799619 60799623 60799624 60799625 60799627 60799629 60799630 60801298 60801322 60801843 60801847 60801848 60801849 60801853 60801854 60805464 60806324 60806335 60806824 60806825 60807429 60807431 60808543 60808553 60808572 60809755 60809764 60810138 60810922 60813934 60813948 60813963 60813967 60814449 60814454 60814456 60814457 60815370 60815373 60815374 60815375 60815378 60815379 60815537 60815538 60815540 60815549 60815551 60815553 60815554 60816263 60816265 60816271 60817271 60817273 60817275 60817279 60817285 60817286 60817289 60817295 60817301 60817303 60817304 60817306 60817307 60817608 60817610 60817611 60818909 60818918 60818925 60818931 60818936 60818937 60818938 60818947 60775559 60808564  
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 323 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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