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U.S. Department of Health and Human Services

Class 2 Device Recall BIOTRONIK ILIVIA

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  Class 2 Device Recall BIOTRONIK ILIVIA 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-1462-2021
Recall Event ID 87549
PMA Number P980023S093 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Code Information Serial Number 61091508 84702943 84730466 84730467 84730473 84731681 84732041 84733171 84733182 84733184 84733566 84733567 84733573 84733576 84733579 84733584 84733789 84733797 84734087 84734093 84734876 84734877 84735634 84735637 84735639 84735642 84737565 84737572 84737578 84737923 84738280 84738281 84738284 84738617 84738620 84738621 84739042 84739049 84739285 84739288 84740027 84740029 84740529 84740981 84741287 84741300 84741301 84741302 84741423 84741558 84741561 84741739 84741883 84741898 84742256 84742261 84743460 84743463 84743908 84743932 84744353 84746458 84746479 84749728 84749736 84753258 84754939 84755554 84755839 84756402 84756412 84761217 84761486 84761780  
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 74 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 = LWS and Original Applicant = BIOTRONIK, INC.
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