Algovita External Pulse Generator Recalled for Connection Issues
QiG Group LLC is recalling 31 Algovita External Pulse Generators because they may fail to connect to external devices, preventing reprogramming and recharging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that prevents reprogramming and recharging, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
QiG Group LLC is recalling 31 units of the Algostim LLC Algovita External Pulse Generator, Trial Stimulator, Model 3400. The recall involves specific serial numbers listed in the agency record. These devices were distributed in Germany and Luxembourg.
The recall was initiated because the implantable pulse generator (IPG) model 2408 had suboptimal performance when establishing a connection to external devices unless they were brought into close proximity, as close as 5 cm. This issue may prevent users from reprogramming the stimulator, adjusting stimulation parameters such as on/off status, intensity, and program selection, or recharging the stimulator.
Consumers with affected devices should contact the recalling firm for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
- Manufacturer
- QiG Group LLC
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Serial Numbers: 01DC94
- 01DC98
- 01DC9B
- 01DCA6
- 01DCB2
- 01DCB3
- 01DCB4
- 01DCB5
- 01DCB6
- 01DCB
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by QiG Group LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · QiG Group LLC
See all →- HighQiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues
FDA (Devices) · 2016-03-30
- HighQiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues
FDA (Devices) · 2016-03-30
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12