Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Recall Z-1194-2016 · Posted 2016-03-18
Recalling FirmQiG Group LLC
Recall StatusTerminated
Product CodeLGW
Date Initiated2016-01-26
Date Terminated2017-04-05
Product Quantity31
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in Germany and Luxembourg.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.