FDA Device recall Z-2572-2018
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 by Livanova Usa, citing unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2572-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-24 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Livanova Usa |
| Distribution | AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI |
Product
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Reason
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
Identifiers
| code_info | Part Number 10-0011-0500; Serial Number (UDI Number): FMT77F2 (01054250257503991117091821FMT77F29910 0011 0500), FKR57F…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), 55 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2572-2018%22
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