FDA Medical Device Recalls (openFDA)
QiG Group LLC: Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
- Recall number
- Z-1194-2016
- Recalling firm
- QiG Group LLC
- Product
- Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
- Status
- Terminated
- Initiated
- 2016-01-26
- Posted
- 2016-03-18
- Terminated
- 2017-04-05
- Reason
- 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
- 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
- 31
- Distribution
- Distributed in Germany and Luxembourg.
- Lot, serial or model codes
- Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB
- 510(k) numbers
- not on file
- PMA numbers
- ["P130028"]
- Product code
- LGW
- Firm FEI
- 3010109865
- Firm city
- Blaine
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28