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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy Programming System

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  Class 2 Device Recall VNS Therapy Programming System see related information
Date Initiated by Firm January 24, 2018
Create Date July 28, 2018
Recall Status1 Terminated 3 on November 29, 2023
Recall Number Z-2572-2018
Recall Event ID 80424
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Code Information Part Number 10-0011-0500; Serial Number (UDI Number): FMT77F2 (01054250257503991117091821FMT77F29910 0011 0500), FKR57F2 (01054250257503991117091821FKR57F29910 0011 0500), FCR77F2 (01054250257503991117091821FCR77F29910 0011 0500), CJR77F2 (01054250257503991117091821CJR77F29910 0011 0500), BNT77F2 (01054250257503991117091821BNT77F29910 0011 0500), BNS77F2 (01054250257503991117091821BNS77F29910 0011 0500), 7XR77F2 (010542502575039911170918217XR77F29910 0011 0500), 7XP57F2 (010542502575039911170918217XP57F29910 0011 0500), 79R77F2 (0105425025750399111709182179R77F29910 0011 0500), 90S77F2 (0105425025750399111709182190S77F29910 0011 0500), 97Q57F2 (0105425025750399111709182197Q57F29910 0011 0500), 6NT77F2 (010542502575039911170918216NT77F29910 0011 0500), 9GP57F2 (010542502575039911170918219GP57F29910 0011 0500), 6KQ57F2 (010542502575039911170918216KQ57F29910 0011 0500), B7Q57F2 (01054250257503991117091821B7Q57F29910 0011 0500), 57P57F2 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DGS77F2 (01054250257503991117092221DGS77F29910 0011 0500), DGP57F2 (01054250257503991117092221DGP57F29910 0011 0500), GZR77F2 (01054250257503991117092221GZR77F29910 0011 0500), D1Q57F2 (01054250257503991117092221D1Q57F29910 0011 0500), CSQ57F2 (01054250257503991117092221CSQ57F29910 0011 0500), CLS77F2 (01054250257503991117092221CLS77F29910 0011 0500), C9YB7F2 (01054250257503991117092221C9YB7F29910 0011 0500), C70C7F2 (01054250257503991117092221C70C7F29910 0011 0500), C1R77F2 (01054250257503991117092221C1R77F29910 0011 0500), 7MS77F2 (010542502575039911170922217MS77F29910 0011 0500), 78YB7F2 (0105425025750399111709222178YB7F29910 0011 0500), 9SQ57F2 (010542502575039911170922219SQ57F29910 0011 0500), 5VQ57F2 (010542502575039911170922215VQ57F29910 0011 0500), 5RQ57F2 (010542502575039911170922215RQ57F29910 0011 0500), B60C7F2 (01054250257503991117092221B60C7F29910 0011 0500), 5NQ57F2 (010542502575039911170922215NQ57F29910 0011 0500), 5MR77F2 (010542502575039911170922215MR77F29910 0011 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DBS77F2 (01054250257503991117100321DBS77F29910 0011 0500), 8JS77F2 (010542502575039911171003218JS77F29910 0011 0500), C0R57F2 (01054250257503991117100421C0R57F29910 0011 0500), BTR77F2 (01054250257503991117100421BTR77F29910 0011 0500), BMYB7F2 (01054250257503991117100421BMYB7F29910 0011 0500), BKR77F2 (01054250257503991117100421BKR77F29910 0011 0500), BBP57F2 (01054250257503991117100421BBP57F29910 0011 0500), B8S77F2 (01054250257503991117100421B8S77F29910 0011 0500)       
Recalling Firm/
Manufacturer		 LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
281-228-7200
Manufacturer Reason
for Recall		 Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Consignees were notified on about 01/24/2018 via URGENT: MEDICAL DEVICE CORRECTION letter. Instructions for physicians with new devices (interrogated for the first time) include to 1) apply the changes and proceed with programming as usual. The warning message requires a mandatory action to Apply Changes. After applying changes, therapy will automatically be programmed to 0 mA. The device may be immediately programmed back on to re-enable therapy. 2) To complete and return the attached Customer Response Form (by fax to (281) 853-1248 or by email to M3000FieldAction@livanova.com. Instructions to physicians with devices that have been implanted (previously interrogated) include 1) Restore the normal and magnet mode stimulation parameters from the Summary screen immediately after the warning message screen. If desired, additional programming changes may be made. 2) For AutoStim (M106 only), detection must be re-enabled first, prior to re-enabling AutoStim therapy. The previous AutoStim parameters are not retained and must be reentered manually. If needed, the previous parameters may be found by ending the session and viewing the Session Report for the generator. 3) Please complete and return the attached Customer Response Form by fax to (281) 853-1248 or by email to M3000FieldAction@livanova.com. Additionally customers were instructed to ensure that this notice is communicated to all relevant personnel within the organization. For questions regarding the information in the letter, please contact Clinical Technical Support at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at cservices@livanova.com.
Quantity in Commerce 243 devices total
Distribution Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
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 = LYJ and Original Applicant = LivaNova USA, Inc.
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