Nuvectra Recalls Algovita Spinal Cord Stimulation Leads Due to Stylet Protrusion
Nuvectra is recalling Algovita Spinal Cord Stimulation System percutaneous leads because the stylet may protrude beyond the distal lead tip.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a reported mechanical defect (stylet protrusion) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Nuvectra is conducting a recall of specific percutaneous leads used in the Algovita Spinal Cord Stimulation System. The affected products include the 8-Electrode Percutaneous Lead Kit, 12-Electrode Percutaneous Lead Kit, and 8-electrode and 12-electrode Percutaneous Trial Lead Kits. These leads are part of a system that delivers electrical stimulation to the spinal epidural space to block pain signals.
The recall is being conducted due to two clinical risks associated with these leads. It has been reported that in some units, the stylet protruded beyond the distal lead tip. The source text does not specify the second clinical risk or provide details on reported injuries or illnesses.
The recall affects 406 units outside the United States and 985 units in the United States. Distribution in the US was nationwide, including states such as California, Texas, and New York, while distribution outside the US included Germany. Patients and healthcare providers should contact Nuvectra or their healthcare provider for instructions on how to proceed with the recall.
The recalled product
- Product
- 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
- Manufacturer
- Nuvectra
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: W2886402
- W2888100
- W2904692
- W2909622
- W2909623
- W2912562
- W2918496
- W2918506
- W2930816
- W2938384
- W2939156
- W2943651
- W2946424
- W2952157
- W2964008
- W2964009
- W2964010
- W2964011
- W2972187
- W2978500
Distribution
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