Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

FDA Recall Z-1193-2016 · Posted 2016-03-18

Recalling FirmQiG Group LLC
Recall StatusTerminated
Product CodeLGW
Date Initiated2016-01-26
Date Terminated2017-04-05
Product Quantity34

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.

Firm Action

Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in Germany and Luxembourg.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑