CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report
Algostim LLC, Algovita Implanted Pulse Generator stimulator recalled
QiG Group is recalling Algostim LLC, Algovita Implanted Pulse Generator stimulator. The recall was initiated on 26 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1192-2016
- FDA event ID
- 73150
- Recalling firm
- QiG Group, Blaine, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2016
- FDA classified
- 18 Mar 2016
- Reported
- 30 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 26 Jan 2016 | Recall initiated by company | |
| 18 Mar 2016 | Classified by FDA | +52 days |
| 30 Mar 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Where it was distributed
Distributed in Germany and Luxembourg.
Questions about this recall
Is Algostim LLC, Algovita Implanted Pulse Generator stimulator recalled?
Yes. QiG Group recalled Algostim LLC, Algovita Implanted Pulse Generator stimulator on 26 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1192-2016.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.
Where was it sold?
Distributed in Germany and Luxembourg.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from QiG Group
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Algostim LLC, Algovita Implanted Pulse Generator stimulator recalled | QiG Group | Device Malfunction | MN |
| Device | CLASS II | Algostim LLC, Algovita External Pulse Generator, Trial Stimulator recalled | QiG Group | Device Malfunction | MN |
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