FDA Device recall Z-0663-2020
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly by Livanova Usa, citing this recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the sel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0663-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-16 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reason
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
Identifiers
| code_info | Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F…Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2 01054250257504811118053121BRQ57F29910-0011-0500 9CP57F2 010542502575048111180529219CP57F29910-0011-0500 HCR77F2 01054250257504811118050421HCR77F29910-0011-0500 H5P57F2 01054250257504811118050321H5P57F29910-0011-0500 19S77F2 0105425025750481111804172119S77F29910-0011-0500 3YFTKJ2 010542502575048111180405213YFTKJ29910-0011-0500 68Q57F2 0105425025750481111803302168Q57F29910-0011-0500 H4S77F2 01054250257504811118031521H4S77F29910-0011-0500 C7KRPJ2 01054250257504811118031521C7KRPJ29910-0011-0500 8WQ77F2 010542502575048111180315218WQ77F29910-0011-0500 1VQ77F2 010542502575048111180315211VQ77F29910-0011-0500 1LJRPJ2 010542502575048111180315211LJRPJ29910-0011-0500 JFJRPJ2 01054250257504811118031421JFJRPJ29910-0011-0500 HVP57F2 01054250257504811118031421HVP57F29910-0011-0500 CBJRPJ2 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0663-2020%22
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