Z-1194-2016Class II

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

Name: Z-1194-2016 Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Creator: QiG Group LLC
Published: 2016-01-26
License: https://open.fda.gov/license/

QiG Group LLC / initiated 2016-01-26 / Terminated / root cause: manufacturing process

FDA source

QiG Group LLC began a recall of Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 on 2016-01-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1194-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-26
Posted: 2016-03-18
Terminated: 2017-04-05
Recalling firm: QiG Group LLC
Product: Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1192-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-18
Z-1193-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-18
Z-1194-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-18

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)