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 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…
    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…
    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…
    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…
    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…
    Category
    Distribution
    43 states
  • 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…
    Category
    Distribution
    43 states