Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

FDA device recall Z-1194-2016 · posted 2016-03-18 · Terminated

Recall details

Recalling firm

QiG Group LLC

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.

Action taken

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

Status

Terminated

Product code

LGW

Quantity affected

31

Distribution

Distributed in Germany and Luxembourg.

Date initiated

2016-01-26

Date posted

2016-03-18

Date terminated

2017-04-05

Location

Blaine, MN