FDA Devices recall · Reported December 18, 2019
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
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 se…
LivaNova USA Inc recalled VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly - a moderate-severity action.
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly was recalled by LivaNova USA Inc in December 18, 2019. Reason: This recall is being initiated due to reports that that the therapy programming tablet with software version …. Check the official notice for the remedy. Verify recall #Z-0663-2020 with the FDA Devices before acting.
The recall
LivaNova USA Inc issued this moderate-severity FDA Devices recall-This recall is being initiated due to reports that that the therapy programming tablet with software version ….
- Moderate
- severity level
- 643 units
- affected scope
- Class II
- classification
- December 18, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0663-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0663-2020 |
| Date reported | December 18, 2019 |
| Date initiated | November 16, 2018 |
| Recalling firm | LivaNova USA Inc |
| Firm location | Houston, TX |
| Affected scope | 643 units |
| Distribution | IL, AK, AL, AR, AZ, CA, 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA ,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0663-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026