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StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for ...

FDA Device Recall #Z-2932-2020 — Class II — July 15, 2020

Recall Summary

Recall Number Z-2932-2020
Classification Class II — Moderate risk
Date Initiated July 15, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stimwave Technologies Inc
Location Pompano Beach, FL
Product Type Devices
Quantity 2197 units

Product Description

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 electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Reason for Recall

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

Distribution Pattern

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 / Code Information

1. 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201261-28, 201261-29, 201261-3, 201261-30, 201261-31, 201261-32, 201261-33, 201261-34, 201261-35, 201261-36, 201261-37, 201261-38, 201261-39, 201261-4, 201261-40, 201261-41, 201261-42, 201261-43, 201261-44, 201261-5, 201261-6, 201261-7, 201261-8, 201261-9, 201260-1, 201260-10, 201260-11, 201260-12, 201260-13, 201260-14, 201260-15, 201260-16, 201260-17, 201260-18, 201260-19, 201260-2, 201260-20, 201260-21, 201260-22, 201260-23, 201260-24, 201260-25, 201260-26, 201260-27, 201260-28, 201260-29, 201260-3, 201260-30, 201260-31, 201260-4, 201260-5, 201260-6, 201260-7, 201260-8, 201260-9, 201259-1, 201259-10, 201259-11, 201259-12, 201259-13, 201259-14, 201259-15, 201259-16, 201259-17, 201259-18, 201259-19, 201259-2, 201259-20, 201259-21, 201259-22, 201259-23, 201259-24, 201259-25, 201259-26, 201259-27, 201259-28, 201259-29, 201259-3, 201259-30, 201259-31, 201259-32, 201259-33, 201259-34, 201259-35, 201259-36, 201259-37, 201259-38, 201259-39, 201259-4, 201259-40, 201259-41, 201259-42, 201259-43, 201259-5, 201259-6, 201259-7, 201259-8, 201259-9, 201176-1, 201176-10, 201176-11, 201176-12, 201176-13, 201176-14, 201176-15, 201176-16, 201176-17, 201176-18, 201176-19, 201176-2, 201176-20, 201176-21, 201176-22, 201176-23, 201176-24, 201176-25, 201176-26, 201176-27, 201176-28, 201176-29, 201176-3, 201176-30, 201176-31, 201176-32, 201176-4, 201176-5, 201176-6, 201176-7, 201176-8, 201176-9; Expansion additional serial numbers: 1. STQ4-SPR-B0 US, Serial Numbers: 211128-13, 211128-14, 211128-15, 211128-16, 2B11671-10, 2B11671-11, 2B11671-12, 2B11671-13, 2B11671-15, 2B11671-16, 2B11671-17, 2B11671-18, 2B11671-19, 2B11671-2, 2B11671-20, 2B11671-21, 2B11671-23, 2B11671-24, 2B11671-25, 2B11671-26, 2B11671-3, 2B11671-31, 2B11671-32, 2B11671-33, 2B11671-35, 2B11671-37, 2B11671-38, 2B11671-39, 2B11671-4, 2B11671-40, 2B11671-43, 2B11671-44, 2B11671-45, 2B11671-46, 2B11671-47, 2B11671-48, 2B11671-49, 2B11671-5, 2B11671-52, 2B11671-53, 2B11671-54, 2B11671-55, 2B11671-56, 2B11671-59, 2B11671-60, 2B11671-62, 2B11671-63, 2B11671-64, 2B11671-65, 2B11671-66, 2B11671-67, 2B11671-68, 2B11671-69, 2B11671-7, 2B11671-70, 2B11671-71, 2B11671-72, 2B11671-73, 2B11671-75, 2B11671-76, 2B11671-77, 2B11671-8, 2B11671-80, 2B11671-81, 2B11671-82, 2B11671-83, 2B11671-84, 2B11671-85, 2B11671-9, 2B11671-90, 2B11671-92, 2B11672-1, 2B11672-11, 2B11672-13, 2B11672-14, 2B11672-15, 2B11672-16, 2B11672-19, 2B11672-2, 2B11672-20, 2B11672-21, 2B11672-22, 2B11672-23, 2B11672-25, 2B11672-27, 2B11672-5, 2B11672-6, 2B11672-7, 2B11672-8, 2B11767-1, 2B11767-10, 2B11767-16, 2B11767-19, 2B11767-2, 2B11767-20, 2B11767-21, 2B11767-22, 2B11767-23, 2B11767-24, 2B11767-25, 2B11767-26, 2B11767-27, 2B11767-28, 2B11767-29, 2B11767-30, 2B11767-31, 2B11767-32, 2B11767-33, 2B11767-36, 2B11767-37, 2B11767-38, 2B11767-42, 2B11767-43, 2B11767-45, 2B11767-46, 2B11767-47, 2B11767-53, 2B11767-54, 2B11767-55, 2B11767-56, 2B11767-60, 2B11767-61, 2B11767-64, 2B11767-65, 2B11767-67, 2B11767-72, 2B11767-73, 2B11767-74, 2B11767-75, 2B11767-84, 2B11767-86, 2B11767-87, 2B11767-88, 2B11767-89, 2B11767-93, 2B11767-94, 2B11767-95, 2B11767-96, 2B11769-1, 2B11769-10, 2B11769-14, 2B11769-16, 2B11769-17, 2B11769-18, 2B11769-19, 2B11769-20, 2B11769-21, 2B11769-22, 2B11769-23, 2B11769-24, 2B11769-25, 2B11769-26, 2B11769-27, 2B11769-28, 2B11769-29, 2B11769-30, 2B11769-31, 2B11769-34, 2B11769-35, 2B11769-37, 2B11769-38, 2B11769-39, 2B11769-4, 2B11769-40, 2B11769-41, 2B11769-42, 2B11769-43, 2B11769-45, 2B11769-46, 2B11769-47, 2B11769-48, 2B11769-49, 2B11769-5, 2B11769-50, 2B11769-51, 2B11769-55, 2B11769-56, 2B11769-57, 2B11769-58, 2B11769-6, 2B11769-60, 2B11769-61, 2B11769-62, 2B11769-63, 2B11769-66, 2B11769-67, 2B11769-68, 2B11769-7, 2B11769-72, 2B11769-73, 2B11769-74, 2B11769-75, 2B11769-76, 2B11769-78, 2B11769-79, 2B11769-80, 2B11769-81, 2B11769-82, 2B11769-83, 2B11769-84, 2B11769-85, 2B11769-89, 2B11769-9, 2B11769-93, 2B11769-97, 2B11881-1, 2B11881-10, 2B11881-11, 2B11881-12, 2B11881-13, 2B11881-14, 2B11881-15, 2B11881-16, 2B11881-17, 2B11881-18, 2B11881-19, 2B11881-2, 2B11881-20, 2B11881-21, 2B11881-22, 2B11881-23, 2B11881-24, 2B11881-25, 2B11881-26, 2B11881-27, 2B11881-3, 2B11881-36, 2B11881-37, 2B11881-38, 2B11881-39, 2B11881-40, 2B11881-41, 2B11881-42, 2B11881-43, 2B11881-44, 2B11881-45, 2B11881-47, 2B11881-5, 2B11881-53, 2B11881-54, 2B11881-55, 2B11881-56, 2B11881-57, 2B11881-58, 2B11881-59, 2B11881-6, 2B11881-60, 2B11881-61, 2B11881-62, 2B11881-63, 2B11881-65, 2B11881-68, 2B11881-71, 2B11881-73, 2B11881-75, 2B11881-78, 2B11881-79, 2B11881-80, 2B11881-81, 2B11881-83, 2B11881-85, 2B11881-86, 2B11881-87, 2B11881-88, 2B11881-89, 2B11881-9, 2B11881-90, 2B11881-91, 2B11881-92, 2B11881-94; 2. STRQ-SPR-B0 EU, Serial Numbers: 211128-1, 211128-17, 211128-19, 211128-20, 211128-21, 211128-24, 211128-27, 211128-28, 211128-30, 211128-32, 211128-46, 211128-47, 211128-60, 211128-61, 211128-95, 2B11767-11, 2B11767-13, 2B11881-34

Other Recalls from Stimwave Technologies Inc

Recall # Classification Product Date
Z-2931-2020 Class II StimQ Peripheral Nerve Stimulator System (PNS) ... Jul 15, 2020
Z-2929-2020 Class II StimQ Peripheral Nerve Stimulator System (PNS) ... Jul 15, 2020
Z-2933-2020 Class II StimQ Peripheral Nerve Stimulator System (PNS) ... Jul 15, 2020
Z-2928-2020 Class II StimQ Peripheral Nerve Stimulator System (PNS) ... Jul 15, 2020
Z-2930-2020 Class II StimQ Peripheral Nerve Stimulator System (PNS) ... Jul 15, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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