CLASS II ONGOING Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
StimQ Peripheral Nerve Stimulator System (PNS) recalled
Stimwave Technologies is recalling StimQ Peripheral Nerve Stimulator System (PNS), distributed nationwide in the US. The recall was initiated on 15 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2933-2020
- FDA event ID
- 86115
- Recalling firm
- Stimwave Technologies, Pompano Beach, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jul 2020
- FDA classified
- 2 Sep 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jul 2020 | Recall initiated by company | |
| 2 Sep 2020 | Classified by FDA | +49 days |
| 9 Sep 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product contains a non-functional component not referenced in product labeling.
Product as listed by the FDA
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 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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is StimQ Peripheral Nerve Stimulator System (PNS) recalled?
Yes. Stimwave Technologies recalled StimQ Peripheral Nerve Stimulator System (PNS) on 15 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2933-2020.
Why was it recalled?
The product contains a non-functional component not referenced in product labeling.
Which lots are affected?
1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stimwave Technologies
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | StimQ Peripheral Nerve Stimulator System (PNS) recalled | Stimwave Technologies | Other | Nationwide |
| Device | CLASS II | StimQ Peripheral Nerve Stimulator System (PNS) recalled | Stimwave Technologies | Other | Nationwide |
| Device | CLASS II | StimQ Peripheral Nerve Stimulator System (PNS) recalled | Stimwave Technologies | Other | Nationwide |
| Device | CLASS II | StimQ Peripheral Nerve Stimulator System (PNS) recalled | Stimwave Technologies | Other | Nationwide |
| Device | CLASS II | StimQ Peripheral Nerve Stimulator System (PNS) recalled | Stimwave Technologies | Other | Nationwide |
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