Nuvectra Algovita Spinal Cord Stimulation Programmer Recall for Software Defect
Nuvectra is recalling 17 Algovita Spinal Cord Stimulation System Clinical Programmers (Model 4500) because a software defect may prevent users from recharging the implantable pulse generator.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where a software defect may prevent recharging of an implanted device, creating a risk of harm (loss of therapy) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Nuvectra is recalling 17 units of the Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. The recall applies to devices with software version v1.1.5. The affected units were distributed in Germany.
The recall is due to a defect in the optional Swap feature. When used, this feature copies programming parameters from the external pulse generator (EPG) to the implantable pulse generator (IPG), but it also copies unintended calibration data. This error may result in the user being unable to recharge the IPG.
Health care professionals using these devices should stop using the optional Swap feature. The recall is limited to the Clinical Programmer Model 4500 and does not affect other components of the Algovita system.
The recalled product
- Product
- Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator…
- Manufacturer
- Nuvectra
- Affected units
- 17
Distribution
Distribution scope not specified by the agency.
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