FDA Device recall Z-2929-2020
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide t…
- FDA Device
- Class II
- ongoing
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide t… by Stimwave Technologies, citing the product contains a non-functional component not referenced in product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2929-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-15 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stimwave Technologies |
| Distribution | US |
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 electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
Reason
The product contains a non-functional component not referenced in product labeling.
Identifiers
| code_info | Serial Numbers: 211662-1, 211662-10, 211662-11, 211662-12, 211662-13, 211662-14, 211662-15, 211662-16, 211662-17, 211…Serial Numbers: 211662-1, 211662-10, 211662-11, 211662-12, 211662-13, 211662-14, 211662-15, 211662-16, 211662-17, 211662-18, 211662-19, 211662-2, 211662-20, 211662-21, 211662-22, 211662-23, 211662-24, 211662-25, 211662-26, 211662-27, 211662-28, 211662-29, 211662-3, 211662-30, 211662-31, 211662-32, 211662-33, 211662-34, 211662-35, 211662-36, 211662-37, 211662-38, 211662-39, 211662-4, 211662-40, 211662-41, 211662-42, 211662-43, 211662-44, 211662-45, 211662-46, 211662-47, 211662-48, 211662-49, 211662-5, 211662-50, 211662-51, 211662-52, 211662-53, 211662-54, 211662-55, 211662-56, 211662-57, 211662-58, 211662-59, 211662-6, 211662-60, 211662-61, 211662-62, 211662-63, 211662-64, 211662-65, 211662-66, 211662-67, 211662-68, 211662-69, 211662-7, 211662-70, 211662-71, 211662-72, 211662-73, 211662-74, 211662-75, 211662-76, 211662-77, 211662-78, 211662-79, 211662-8, 211662-80, 211662-81, 211662-82, 211662-83, 211662-84, 211662-85, 211662-86, 211662-87, 211662-88, 211662-89, 211662-9, 211662-90, 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2929-2020%22
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