VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
FDA Device Recall #Z-2572-2018 — Class II — January 24, 2018
Recall Summary
| Recall Number | Z-2572-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 24, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LivaNova USA Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 243 devices total |
Product Description
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reason for Recall
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Distribution Pattern
Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
Lot / 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 (0105425025750399111709182157P57F29910 0011 0500), 55T77F2 (0105425025750399111709182155T77F29910 0011 0500), J6R57F2 (01054250257503991117091821J6R57F29910 0011 0500), HWR77F2 (01054250257503991117091821HWR77F29910 0011 0500), 1G7G1F2 (010542502575039911170918211G7G1F29910 0011 0500), 1JR57F2 (010542502575039911170918211JR57F29910 0011 0500), 9XP57F2 (010542502575039911170919219XP57F29910 0011 0500), 4LR77F2 (010542502575039911170919214LR77F29910 0011 0500), 4GT77F2 (010542502575039911170919214GT77F29910 0011 0500), 4GR57F2 (010542502575039911170919214GR57F29910 0011 0500), 2DT77F2 (010542502575039911170919212DT77F29910 0011 0500), G2S77F2 (01054250257503991117092021G2S77F29910 0011 0500), FVQ77F2 (01054250257503991117092021FVQ77F29910 0011 0500), G5T77F2 (01054250257503991117092021G5T77F29910 0011 0500), FDQ57F2 (01054250257503991117092021FDQ57F29910 0011 0500), F5R57F2 (01054250257503991117092021F5R57F29910 0011 0500), F2R57F2 (01054250257503991117092021F2R57F29910 0011 0500), F1Q57F2 (01054250257503991117092021F1Q57F29910 0011 0500), GHS77F2 (01054250257503991117092021GHS77F29910 0011 0500), DVR77F2 (01054250257503991117092021DVR77F29910 0011 0500), DNP57F2 (01054250257503991117092021DNP57F29910 0011 0500), DMYB7F2 (01054250257503991117092021DMYB7F29910 0011 0500), DJS77F2 (01054250257503991117092021DJS77F29910 0011 0500), D1R57F2 (01054250257503991117092021D1R57F29910 0011 0500), CVQ57F2 (01054250257503991117092021CVQ57F29910 0011 0500), H4R57F2 (01054250257503991117092021H4R57F29910 0011 0500), 85S77F2 (0105425025750399111709202185S77F29910 0011 0500), 89T77F2 (0105425025750399111709202189T77F29910 0011 0500), 8LYB7F2 (010542502575039911170920218LYB7F29910 0011 0500), 97YB7F2 (0105425025750399111709202197YB7F29910 0011 0500), 6MQ57F2 (010542502575039911170920216MQ57F29910 0011 0500), 6CQ57F2 (010542502575039911170920216CQ57F29910 0011 0500), 5HS77F2 (010542502575039911170920215HS77F29910 0011 0500), JLQ57F2 (01054250257503991117092021JLQ57F29910 0011 0500), JGS77F2 (01054250257503991117092021JGS77F29910 0011 0500), 11R57F2 (0105425025750399111709202111R57F29910 0011 0500), 1TQ57F2 (010542502575039911170920211TQ57F29910 0011 0500), 1YR77F2 (010542502575039911170920211YR77F29910 0011 0500), 2DR77F2 (010542502575039911170921212DR77F29910 0011 0500), FXP57F2 (01054250257503991117092121FXP57F29910 0011 0500), FTR77F2 (01054250257503991117092121FTR77F29910 0011 0500), FPQ57F2 (01054250257503991117092121FPQ57F29910 0011 0500), FNQ57F2 (01054250257503991117092121FNQ57F29910 0011 0500), FLYB7F2 (01054250257503991117092121FLYB7F29910 0011 0500), FFP57F2 (01054250257503991117092121FFP57F29910 0011 0500), GGT77F2 (01054250257503991117092121GGT77F29910 0011 0500), GSQ57F2 (01054250257503991117092121GSQ57F29910 0011 0500), CMS77F2 (01054250257503991117092121CMS77F29910 0011 0500), H1R77F2 (01054250257503991117092121H1R77F29910 0011 0500), H3R57F2 (01054250257503991117092121H3R57F29910 0011 0500), 7LS77F2 (010542502575039911170921217LS77F29910 0011 0500), 9KR57F2 (010542502575039911170921219KR57F29910 0011 0500), 9NS77F2 (010542502575039911170921219NS77F29910 0011 0500), 65R57F2 (0105425025750399111709212165R57F29910 0011 0500), B8R77F2 (01054250257503991117092121B8R77F29910 0011 0500), 5D0C7F2 (010542502575039911170921215D0C7F29910 0011 0500), B9YB7F2 (01054250257503991117092121B9YB7F29910 0011 0500), BJR57F2 (01054250257503991117092121BJR57F29910 0011 0500), JCQ57F2 (01054250257503991117092121JCQ57F29910 0011 0500), J9YB7F2 (01054250257503991117092121J9YB7F29910 0011 0500), HMYB7F2 (01054250257503991117092121HMYB7F29910 0011 0500), CDQ57F2 (01054250257503991117092121CDQ57F29910 0011 0500), FXQ57F2 (01054250257503991117092221FXQ57F29910 0011 0500), G5S77F2 (01054250257503991117092221G5S77F29910 0011 0500), G3R77F2 (01054250257503991117092221G3R77F29910 0011 0500), FRQ57F2 (01054250257503991117092221FRQ57F29910 0011 0500), G7YB7F2 (01054250257503991117092221G7YB7F29910 0011 0500), FLS77F2 (01054250257503991117092221FLS77F29910 0011 0500), G90C7F2 (01054250257503991117092221G90C7F29910 0011 0500), FGR77F2 (01054250257503991117092221FGR77F29910 0011 0500), FFT77F2 (01054250257503991117092221FFT77F29910 0011 0500), FCT77F2 (01054250257503991117092221FCT77F29910 0011 0500), G9R57F2 (01054250257503991117092221G9R57F29910 0011 0500), F9YB7F2 (01054250257503991117092221F9YB7F29910 0011 0500), F9S77F2 (01054250257503991117092221F9S77F29910 0011 0500), F8T77F2 (01054250257503991117092221F8T77F29910 0011 0500), GDQ57F2 (01054250257503991117092221GDQ57F29910 0011 0500), F7R57F2 (01054250257503991117092221F7R57F29910 0011 0500), F4T77F2 (01054250257503991117092221F4T77F29910 0011 0500), DWR77F2 (01054250257503991117092221DWR77F29910 0011 0500), DTR77F2 (01054250257503991117092221DTR77F29910 0011 0500), GMQ57F2 (01054250257503991117092221GMQ57F29910 0011 0500), DLS77F2 (01054250257503991117092221DLS77F29910 0011 0500), DH0C7F2 (01054250257503991117092221DH0C7F29910 0011 0500), 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 0500), 5KS77F2 (010542502575039911170922215KS77F29910 0011 0500), B8T77F2 (01054250257503991117092221B8T77F29910 0011 0500), BHP57F2 (01054250257503991117092221BHP57F29910 0011 0500), BJR77F2 (01054250257503991117092221BJR77F29910 0011 0500), 4JS77F2 (010542502575039911170922214JS77F29910 0011 0500), H4T77F2 (01054250257503991117092221H4T77F29910 0011 0500), JZQ57F2 (01054250257503991117092221JZQ57F29910 0011 0500), JMS77F2 (01054250257503991117092221JMS77F29910 0011 0500), JMQ57F2 (01054250257503991117092221JMQ57F29910 0011 0500), JG0C7F2 (01054250257503991117092221JG0C7F29910 0011 0500), JBQ57F2 (01054250257503991117092221JBQ57F29910 0011 0500), J8T77F2 (01054250257503991117092221J8T77F29910 0011 0500), HZQ57F2 (01054250257503991117092221HZQ57F29910 0011 0500), J7R57F2 (01054250257503991117092221J7R57F29910 0011 0500), HVR77F2 (01054250257503991117092221HVR77F29910 0011 0500), HTP57F2 (01054250257503991117092221HTP57F29910 0011 0500), HNS77F2 (01054250257503991117092221HNS77F29910 0011 0500), HMQ57F2 (01054250257503991117092221HMQ57F29910 0011 0500), HKQ57F2 (01054250257503991117092221HKQ57F29910 0011 0500), H7S77F2 (01054250257503991117092221H7S77F29910 0011 0500), D3R57F2 (01054250257503991117092221D3R57F29910 0011 0500), 1HT77F2 (010542502575039911170922211HT77F29910 0011 0500), 1MYB7F2 (010542502575039911170922211MYB7F29910 0011 0500), 2CP57F2 (010542502575039911170922212CP57F29910 0011 0500), 2LYB7F2 (010542502575039911170922212LYB7F29910 0011 0500), CLYB7F2 (01054250257503991117092321CLYB7F29910 0011 0500), CMYB7F2 (01054250257503991117092321CMYB7F29910 0011 0500), B2S77F2 (01054250257503991117092321B2S77F29910 0011 0500), B0R57F2 (01054250257503991117092321B0R57F29910 0011 0500), 9QS77F2 (010542502575039911170923219QS77F29910 0011 0500), D8Q57F2 (01054250257503991117092321D8Q57F29910 0011 0500), 960C7F2 (01054250257503991117092321960C7F29910 0011 0500), 95T77F2 (0105425025750399111709232195T77F29910 0011 0500), 8JR77F2 (010542502575039911170923218JR77F29910 0011 0500), 8HR57F2 (010542502575039911170923218HR57F29910 0011 0500), BXP57F2 (01054250257503991117092521BXP57F29910 0011 0500), BWR77F2 (01054250257503991117092521BWR77F29910 0011 0500), BTQ77F2 (01054250257503991117092521BTQ77F29910 0011 0500), C8YB7F2 (01054250257503991117092521C8YB7F29910 0011 0500), C60C7F2 (01054250257503991117092521C60C7F29910 0011 0500), BLR77F2 (01054250257503991117092521BLR77F29910 0011 0500), BLQ57F2 (01054250257503991117092521BLQ57F29910 0011 0500), BGR77F2 (01054250257503991117092521BGR77F29910 0011 0500), BGP57F2 (01054250257503991117092521BGP57F29910 0011 0500), CHQ57F2 (01054250257503991117092521CHQ57F29910 0011 0500), CKR57F2 (01054250257503991117092521CKR57F29910 0011 0500), CPP57F2 (01054250257503991117092521CPP57F29910 0011 0500), CSR77F2 (01054250257503991117092521CSR77F29910 0011 0500), CTQ77F2 (01054250257503991117092521CTQ77F29910 0011 0500), CXR77F2 (01054250257503991117092521CXR77F29910 0011 0500), 9MS77F2 (010542502575039911170925219MS77F29910 0011 0500), 9JR77F2 (010542502575039911170925219JR77F29910 0011 0500), 9DQ57F2 (010542502575039911170925219DQ57F29910 0011 0500), D7S77F2 (01054250257503991117092521D7S77F29910 0011 0500), 94T77F2 (0105425025750399111709252194T77F29910 0011 0500), 8PQ57F2 (010542502575039911170925218PQ57F29910 0011 0500), BWQ77F2 (01054250257503991117092721BWQ77F29910 0011 0500), BSR77F2 (01054250257503991117092721BSR77F29910 0011 0500), C9R57F2 (01054250257503991117092721C9R57F29910 0011 0500), C8R57F2 (01054250257503991117092721C8R57F29910 0011 0500), C5R57F2 (01054250257503991117092721C5R57F29910 0011 0500), CF0C7F2 (01054250257503991117092721CF0C7F29910 0011 0500), C3R57F2 (01054250257503991117092721C3R57F29910 0011 0500), CFP57F2 (01054250257503991117092721CFP57F29910 0011 0500), BDT77F2 (01054250257503991117092721BDT77F29910 0011 0500), B9S77F2 (01054250257503991117092721B9S77F29910 0011 0500), B5R57F2 (01054250257503991117092721B5R57F29910 0011 0500), CPQ57F2 (01054250257503991117092721CPQ57F29910 0011 0500), B4R57F2 (01054250257503991117092721B4R57F29910 0011 0500), D2R57F2 (01054250257503991117092721D2R57F29910 0011 0500), 9KQ57F2 (010542502575039911170927219KQ57F29910 0011 0500), D5R77F2 (01054250257503991117092721D5R77F29910 0011 0500), 980C7F2 (01054250257503991117092721980C7F29910 0011 0500), D9YB7F2 (01054250257503991117092721D9YB7F29910 0011 0500), 8WR77F2 (010542502575039911170927218WR77F29910 0011 0500), DB0C7F2 (01054250257503991117092721DB0C7F29910 0011 0500), 9P7G1F2 (010542502575039911170928219P7G1F29910 0011 0500), D3S77F2 (01054250257503991117092821D3S77F29910 0011 0500), D6R57F2 (01054250257503991117092821D6R57F29910 0011 0500), D7R57F2 (01054250257503991117092821D7R57F29910 0011 0500), 9CR77F2 (010542502575039911170928219CR77F29910 0011 0500), 9G0C7F2 (010542502575039911170928219G0C7F29910 0011 0500), 96R57F2 (0105425025750399111709282196R57F29910 0011 0500), DFP57F2 (01054250257503991117092821DFP57F29910 0011 0500), C0S77F2 (01054250257503991117092921C0S77F29910 0011 0500), BN7G1F2 (01054250257503991117092921BN7G1F29910 0011 0500), BQ7G1F2 (01054250257503991117092921BQ7G1F29910 0011 0500), C8S77F2 (01054250257503991117092921C8S77F29910 0011 0500), CB0C7F2 (01054250257503991117092921CB0C7F29910 0011 0500), CCR77F2 (01054250257503991117092921CCR77F29910 0011 0500), BHR57F2 (01054250257503991117092921BHR57F29910 0011 0500), CHP57F2 (01054250257503991117092921CHP57F29910 0011 0500), BCR77F2 (01054250257503991117092921BCR77F29910 0011 0500), BBR77F2 (01054250257503991117092921BBR77F29910 0011 0500), BB0C7F2 (01054250257503991117092921BB0C7F29910 0011 0500), B90C7F2 (01054250257503991117092921B90C7F29910 0011 0500), B70C7F2 (01054250257503991117092921B70C7F29910 0011 0500), B2R57F2 (01054250257503991117092921B2R57F29910 0011 0500), 9VP57F2 (010542502575039911170929219VP57F29910 0011 0500), 9TQ57F2 (010542502575039911170929219TQ57F29910 0011 0500), 9GR57F2 (010542502575039911170929219GR57F29910 0011 0500), 9FP57F2 (010542502575039911170929219FP57F29910 0011 0500), 9BS77F2 (010542502575039911170929219BS77F29910 0011 0500), 98R57F2 (0105425025750399111709292198R57F29910 0011 0500), D80C7F2 (01054250257503991117092921D80C7F29910 0011 0500), 970C7F2 (01054250257503991117092921970C7F29910 0011 0500), D8YB7F2 (01054250257503991117092921D8YB7F29910 0011 0500), 95R77F2 (0105425025750399111709292195R77F29910 0011 0500), 8YR77F2 (010542502575039911170929218YR77F29910 0011 0500), C80C7F2 (01054250257503991117100321C80C7F29910 0011 0500), CNS77F2 (01054250257503991117100321CNS77F29910 0011 0500), 9VQ77F2 (010542502575039911171003219VQ77F29910 0011 0500), D4T77F2 (01054250257503991117100321D4T77F29910 0011 0500), 9DR77F2 (010542502575039911171003219DR77F29910 0011 0500), 91R57F2 (0105425025750399111710032191R57F29910 0011 0500), 8VQ77F2 (010542502575039911171003218VQ77F29910 0011 0500), 8RQ57F2 (010542502575039911171003218RQ57F29910 0011 0500), 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)
Other Recalls from LivaNova USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0535-2021 | Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usag... | Nov 12, 2020 |
| Z-0462-2021 | Class II | VNS Therapy¿ AspireSR¿ Generator | Sep 28, 2020 |
| Z-1563-2020 | Class II | VNS Therapy Programmer, Model 3000 used with Mo... | Feb 4, 2020 |
| Z-0561-2020 | Class I | VNS Therapy, SenTiva, Model # 1000, (01)0542502... | Aug 22, 2019 |
| Z-1118-2020 | Class II | VNS Therapy SENTIVA Generator Model # 1000 ... | Aug 13, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.