The Recall Desk

FDA (Devices) recall action 86115

Stimwave Technologies Inc recalled 6 products on 2020-09-09

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-09-09
Critical
0
Units
7,634

Why these products were recalled

The product contains a non-functional component not referenced in product labeling.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component

    Stimwave Technologies is recalling six StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elec
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical cu
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,550 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elect
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrica
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,444 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical c
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,197 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elect
    Category
    Distribution
    43 states