Algostim LLC — Class II medical device recall Z-1194-2016
Terminated recall by QiG Group LLC, reported 2016-03-30. The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the e
| Recall number | Z-1194-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QiG Group LLC, Blaine, MN, United States |
| Recall initiated | 2016-01-26 |
| Classified | 2016-03-18 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-04-05 |
| Countries outside the US | DE, LU |
| Quantity | 31 |
| Serial numbers | 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6 |
| Model numbers | 3400 |
Product
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1194-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.