Severity
Moderate
ModerateClass IIOngoing
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0663-2020) was formally reported on December 18, 2019, with the manufacturer initiating the action on November 16, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. LivaNova USA Inc is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 643 units.
The documented reason for this recall is: 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 1… Distribution data in the federal record shows the product reached: 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, …. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
643 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly. Recalled by LivaNova USA Inc. Units affected: 643 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0663-2020.
Where was the recalled product distributed? ▼
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 , WI, WV, WY,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0663-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 18, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.