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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighNuvectra Algovita Spinal Cord Stimulation Programmer Recall for Software Defect
FDA (Devices) · 2016-05-11
- HighAbbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically
FDA (Devices) · 2024-07-10
- HighDeep brain stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- SevereAbbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure
FDA (Devices) · 2023-09-20
- SevereInfinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure
FDA (Devices) · 2023-09-20
- HighSpinal cord stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19