FDA Medical Device Recalls (openFDA)
Stimwave Technologies Inc: 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 electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
- Recall number
- Z-2931-2020
- Recalling firm
- Stimwave Technologies Inc
- 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 electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
- Status
- Open, Classified
- Initiated
- 2020-07-15
- Posted
- 2020-09-02
- Terminated
- not on file
- Reason
- The product contains a non-functional component not referenced in product labeling.
- Root cause
- Under Investigation by firm
- Action
- Field Safety Correction/Advisory Notices were sent to Distributors, Regional Sales Directors, and Territory Managers via email on 07/15/2020, describing the issue, recall instructions and their responsibilities. Prior to this communication, these parties received training on 07/13/2020 on the field action activities identifying the issue, instructions, and their responsibilities as explained in the letter. A physician letter was issued on 08/06/2020 to inform physicians of the recall.
- Quantity
- 6 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
- Lot, serial or model codes
- FR4A-SPR-BO-US, Serial Numbers: 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, 210431-93;
- 510(k) numbers
- ["K152178","K171366"]
- PMA numbers
- not on file
- Product code
- GZF
- Firm FEI
- 3010676138
- Firm city
- Pompano Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28