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U.S. Department of Health and Human Services

Class 2 Device Recall Algovita Stimulator

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  Class 2 Device Recall Algovita Stimulator see related information
Date Initiated by Firm January 26, 2016
Date Posted March 18, 2016
Recall Status1 Terminated 3 on April 05, 2017
Recall Number Z-1194-2016
Recall Event ID 73150
PMA Number P130028 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Code Information Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB 
Recalling Firm/
Manufacturer		 QiG Group LLC
10675 Naples St NE
Blaine MN 55449-5802
Manufacturer Reason
for Recall		 The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms.
Quantity in Commerce 31
Distribution Distributed in Germany and Luxembourg.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = Nuvectra Corporation
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