Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 28, 2016
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovi
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System.…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nuvectra recalled Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Le… - a moderate-severity action.
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Le… was recalled by Nuvectra in December 28, 2016. Reason: Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous lead…. Check the official notice for the remedy. Verify recall #Z-0781-2017 with the FDA Devices before acting.
The recall
Nuvectra issued this moderate-severity FDA Devices recall-Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous lead….
- Moderate
- severity level
- Class II
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0781-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0781-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on October 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Nuvectra is listed as the recalling firm, operating out of Blaine, MN. Federal records list the affected scope as 406 OUS, 985 US.
The documented reason for this recall is: Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some perc… Distribution data in the federal record shows the product reached: US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany. 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
406 OUS, 985 US
Related Recalls
6
3 from same agency
Product description
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient s use of the system.
Reason for recall
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0781-2017 |
| Date reported | December 28, 2016 |
| Date initiated | October 11, 2016 |
| Recalling firm | Nuvectra |
| Firm location | Blaine, MN |
| Affected scope | 406 OUS, 985 US |
| Distribution | US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany |
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-0781-2017) 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? ▼
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient s use of the system.. Recalled by Nuvectra. Units affected: 406 OUS, 985 US.
Why was this product recalled? ▼
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0781-2017.
Where was the recalled product distributed? ▼
Distribution: US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0781-2017) 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 28, 2016. 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.