QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues
QiG Group LLC is recalling 40 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close.
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 essential operations like reprogramming and recharging. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' as the device failure could lead to unintended stimulation or loss of therapy, but no specific injuries are cited in the source text.
Plain-English summary
QiG Group LLC is recalling 40 units of the Algovita Implanted Pulse Generator stimulator, Model 2408 (3 x 8 channel). The recall involves devices distributed in Germany and Luxembourg.
The recall was issued because the implantable pulse generators had suboptimal performance when establishing a connection to external devices. The devices required external devices to be brought into close proximity, as close as 5 cm, to function properly. As a result, specific functions may not be available, including reprogramming the stimulator, adjusting stimulation parameters such as on/off status, intensity modifications, and stimulation program selection, and recharging the stimulator.
Affected units have specific serial numbers listed in the official recall notice. Consumers or healthcare providers with these devices should contact the recalling firm for further instructions.
The recalled product
- Product
- Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
- Manufacturer
- QiG Group LLC
- Affected units
- 40
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 (20)
- Serial Numbers: 03EDBF
- 03EDC1
- 03EDC5
- 03EDC7
- 03EDC9
- 03EDCA
- 03EDCE
- 03EDD0
- 03EDE5
- 03EDE8
- 03EDE9
- 03EDEA
- 03EDEF
- 03EDF0
- 03EE01
- 03EE03
- 03EE05
- 03EE1C
- 03EE1F
- 03EE24
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
- HighAlgovita External Pulse Generator Recalled for Connection Issues
FDA (Devices) · 2016-03-30
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