Reported Dec 28, 2016 · Terminated
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord…
Nuvectra
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nuvectra · 10675 Naples St NE · Blaine, MN · 55449-5802
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
196 of 196 codes
W2886402W2888100W2904692W2909622W2909623W2912562W2918496W2918506W2930816W2930816W2938384W2939156W2943651W2946424W2952157W2964008W2964009W2964009W2964010W2964010W2964011W2972187W2978500W2981155W2981155W2988382W2988382W3040781W3041965W3041965W3043467W3048908W3052511W3052514W3052515W3057023W3057024W3057027W3057033W3057033W3063066W3063073W3063073W3088964W3110760W3111249W3114108W3119243W3123219W3123220W3123220W3124197W3127472W3127472W3127473W3133254W3133264W3135521W3232789W3232789
- Lot Numbers
- Amount recalled
- 406 OUS, 985 US
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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