Stimwave Technologies Inc recalls StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. F
Recalled 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 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.
Hazard / Issue
The product contains a non-functional component not referenced in product labeling.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1. FR4A-TRL-BO-US, Serial Numbers: 211666-1, 211666-10, 211666-11, 211666-12, 211666-13, 211666-14, 211666-15, 211666-16, 211666-17, 211666-18, 211666-19, 211666-2, 211666-20, 211666-21, 211666-22, 211666-23, 211666-24, 211666-25, 211666-26, 211666-27, 211666-28, 211666-29, 211666-3, 211666-30, 211666-31, 211666-32, 211666-33, 211666-34, 211666-35, 211666-36, 211666-37, 211666-38, 211666-39, 211666-4, 211666-40, 211666-41, 211666-42, 211666-43, 211666-44, 211666-45, 211666-46, 211666-47, 211666-48, 211666-49, 211666-5, 211666-50, 211666-51, 211666-52, 211666-53, 211666-54, 211666-55, 211666-56, 211666-57, 211666-58, 211666-59, 211666-6, 211666-60, 211666-61, 211666-62, 211666-63, 211666-64, 211666-65, 211666-66, 211666-67, 211666-68, 211666-69, 211666-7, 211666-70, 211666-71, 211666-72, 211666-73, 211666-74, 211666-75, 211666-76, 211666-77, 211666-78, 211666-79, 211666-8, 211666-80, 211666-81, 211666-82, 211666-83, 211666-84, 211666-85, 211666-86, 211666-87, 211666-88, 211666-89, 211666-9, 211666-90, 211666-91, 211666-92, 211666-93, 211666-94, 211666-95, 211666-96, 211666-97, 211666-98, , 211614-1, 211614-10, 211614-11, 211614-12, 211614-13, 211614-14, 211614-15, 211614-16, 211614-17, 211614-18, 211614-19, 211614-2, 211614-20, 211614-21, 211614-22, 211614-23, 211614-24, 211614-25, 211614-26, 211614-27, 211614-28, 211614-29, 211614-3, 211614-30, 211614-31, 211614-32, 211614-33, 211614-34, 211614-35, 211614-36, 211614-37, 211614-38, 211614-39, 211614-4, 211614-40, 211614-41, 211614-42, 211614-43, 211614-44, 211614-45, 211614-46, 211614-47, 211614-48, 211614-49, 211614-5, 211614-50, 211614-51, 211614-52, 211614-53, 211614-54, 211614-55, 211614-56, 211614-57, 211614-58, 211614-59, 211614-6, 211614-60, 211614-61, 211614-62, 211614-63, 211614-64, 211614-65, 211614-66, 211614-67, 211614-68, 211614-69, 211614-7, 211614-70, 211614-71, 211614-72, 211614-73, 211614-74, 211614-75, 211614-76, 211614-77, 211614-78, 211614-79, 211614-8, 211614-80, 211614-81, 211614-82, 211614-83, 211614-84, 211614-85, 211614-86, 211614-87, 211614-88, 211614-89, 211614-9, 211614-90, 211614-91, 211614-92, 211614-93, 211614-94, 211614-95, , , 211579-1, 211579-10, 211579-11, 211579-12, 211579-13, 211579-14, 211579-15, 211579-16, 211579-17, 211579-18, 211579-19, 211579-2, 211579-20, 211579-21, 211579-22, 211579-23, 211579-24, 211579-25, 211579-26, 211579-30, 211579-31, 211579-32, 211579-33, 211579-34, 211579-35, 211579-36, 211579-37, 211579-38, 211579-4, 211579-40, 211579-41, 211579-42, 211579-43, 211579-45, 211579-46, 211579-49, 211579-5, 211579-50, 211579-51, 211579-52, 211579-53, 211579-54, 211579-55, 211579-56, 211579-57, 211579-58, 211579-59, 211579-6, 211579-61, 211579-62, 211579-63, 211579-64, 211579-65, 211579-66, 211579-67, 211579-68, 211579-69, 211579-7, 211579-70, 211579-71, 211579-72, 211579-73, 211579-74, 211579-75, 211579-76, 211579-77, 211579-78, 211579-79, 211579-8, 211579-80, 211579-81, 211579-82, 211579-83, 211579-84, 211579-85, 211579-86, 211579-87, 211579-88, 211579-89, 211579-9, 211579-90, 211579-91, 211579-95, 211579-97, 211579-98, , 211578-1, 211578-10, 211578-11, 211578-12, 211578-13, 211578-14, 211578-15, 211578-16, 211578-17, 211578-18, 211578-19, 211578-2, 211578-20, 211578-21, 211578-22, 211578-23, 211578-24, 211578-25, 211578-26, 211578-27, 211578-28, 211578-29, 211578-3, 211578-30, 211578-31, 211578-32, 211578-33, 211578-34, 211578-35, 211578-36, 211578-37, 211578-38, 211578-39, 211578-4, 211578-40, 211578-41, 211578-42, 211578-43, 211578-44, 211578-45, 211578-46, 211578-47, 211578-48, 211578-49, 211578-5, 211578-50, 211578-51, 211578-52, 211578-53, 211578-54, 211578-55, 211578-56, 211578-57, 211578-58, 211578-59, 211578-6, 211578-60, 211578-61, 211578-62, 211578-63, 211578-64, 211578-65, 211578-66, 211578-67, 211578-68, 211578-69, 211578-7, 211578-70, 211578-71, 211578-72, 211578-73, 211578-74, 211578-75, 211578-76, 211578-77, 211578-78, 211578-79, 211578-8, 211578-80, 211578-81, 211578-82, 211578-83, 211578-84, 211578-85, 211578-86, 211578-87, 211578-88, 211578-89, 211578-9, 211578-90, 211578-91, 211578-92, , 2B10866-1, 2B10866-2, 2B10866-3, 2B10866-4, 2B10866-5, 2B10866-6, 2B10866-7, 2B10866-8, 2B10866-9, 2B10866-10, 2B10866-11, 2B10866-12, 2B10866-13, 2B10866-14, 2B10866-15, 2B10866-16, 2B10866-17, 2B10866-18, 2B10866-19, 2B10866-20, 2B10866-21, 2B10866-22, 2B10866-23, 2B10866-24, 2B10866-25, 2B10866-26, 2B10866-27, 2B10866-28, 2B10866-29, 2B10866-30, 2B10866-31, 2B10866-32, 2B10866-33, 2B10866-34, 2B10866-35, 2B10866-36, 2B10866-37, 2B10866-38, 2B10866-39, 2B10866-40, 2B10866-41, 2B10866-42, 2B10866-43, 2B10866-44, 2B10866-45, 2B10866-46, 2B10866-47, 2B10866-48, 2B10866-49, 2B10866-50, 2B10866-51, 2B10866-52, 2B10866-53, 2B10866-54, 2B10866-55, 2B10866-56, 2B10866-57, 2B10866-58, 2B10866-59, 2B10866-60, 2B10866-61, 2B10866-62, 2B10866-63, 2B10866-64, 2B10866-65, 2B10866-66, 2B10866-67, 2B10866-68, 2B10866-69, 2B10866-70, 2B10866-71, 2B10866-72, 2B10866-73, 2B10866-74, 2B10866-75, 2B10866-76, 2B10866-77, 2B10866-78, 2B10866-79, 2B10866-80, 2B10866-81, 2B10866-82, 2B10866-83, 2B10866-84, 2B10866-85, 2B10866-86, 2B10866-87, 2B10866-88, 2B10866-89, 2B10866-90, 2B10866-91, 2B10866-92, 2B10866-93, 2B10866-94, 2B10866-95, 2B10866-96, 2B10866-97, 2B10866-98, 2B10866-99, 2B10866-100, 2B10866-101, 2B10866-102, 2B10866-103, 2B10866-104, 2B10866-105, 2B10866-106, 2B10866-107, 2B10866-108, 2B10866-109, 2B10866-110, 2B10866-111, 2B10866-112, 2B10866-113, 2B10866-114, 2B10866-115, 2B10866-116, 2B10866-117, 2B10866-118, 2B10866-119, 2B10866-120, , 210860-1, 210860-10, 210860-11, 210860-12, 210860-13, 210860-14, 210860-15, 210860-16, 210860-17, 210860-18, 210860-19, 210860-2, 210860-20, 210860-21, 210860-22, 210860-23, 210860-24, 210860-25, 210860-26, 210860-27, 210860-28, 210860-29, 210860-3, 210860-30, 210860-31, 210860-32, 210860-33, 210860-34, 210860-35, 210860-36, 210860-37, 210860-38, 210860-39, 210860-4, 210860-40, 210860-41, 210860-42, 210860-43, 210860-44, 210860-45, 210860-46, 210860-47, 210860-48, 210860-49, 210860-5, 210860-50, 210860-51, 210860-52, 210860-53, 210860-54, 210860-55, 210860-56, 210860-57, 210860-58, 210860-59, 210860-6, 210860-60, 210860-61, 210860-62, 210860-63, 210860-64, 210860-65, 210860-66, 210860-67, 210860-68, 210860-69, 210860-7, 210860-70, 210860-71, 210860-72, 210860-73, 210860-74, 210860-75, 210860-76, 210860-77, 210860-78, 210860-79, 210860-8, 210860-80, 210860-81, 210860-82, 210860-83, 210860-84, 210860-9, , 210432-1, 210432-10, 210432-11, 210432-12, 210432-13, 210432-14, 210432-15, 210432-16, 210432-17, 210432-18, 210432-19, 210432-2, 210432-20, 210432-21, 210432-22, 210432-23, 210432-24, 210432-25, 210432-26, 210432-27, 210432-28, 210432-29, 210432-3, 210432-30, 210432-31, 210432-32, 210432-33, 210432-34, 210432-35, 210432-36, 210432-37, 210432-38, 210432-39, 210432-4, 210432-40, 210432-41, 210432-42, 210432-43, 210432-44, 210432-45, 210432-46, 210432-47, 210432-48, 210432-49, 210432-5, 210432-50, 210432-51, 210432-52, 210432-53, 210432-54, 210432-55, 210432-56, 210432-57, 210432-58, 210432-59, 210432-6, 210432-60, 210432-61, 210432-62, 210432-63, 210432-64, 210432-65, 210432-66, 210432-67, 210432-68, 210432-69, 210432-7, 210432-70, 210432-71, 210432-72, 210432-73, 210432-74, 210432-75, 210432-76, 210432-77, 210432-78, 210432-79, 210432-8, 210432-80, 210432-81, 210432-82, 210432-9, , 210431-1, 210431-10, 210431-13, 210431-15, 210431-2, 210431-21, 210431-22, 210431-3, 210431-4, 210431-53, 210431-61, 210431-68, 210431-74, , 210430-1, 210430-10, 210430-11, 210430-12, 210430-13, 210430-14, 210430-15, 210430-16, 210430-17, 210430-18, 210430-19, 210430-2, 210430-20, 210430-21, 210430-22, 210430-23, 210430-24, 210430-25, 210430-26, 210430-27, 210430-28, 210430-29, 210430-3, 210430-30, 210430-31, 210430-32, 210430-33, 210430-34, 210430-35, 210430-36, 210430-37, 210430-38, 210430-39, 210430-4, 210430-40, 210430-41, 210430-42, 210430-43, 210430-44, 210430-45, 210430-46, 210430-47, 210430-48, 210430-49, 210430-5, 210430-50, 210430-51, 210430-52, 210430-53, 210430-54, 210430-55, 210430-56, 210430-57, 210430-58, 210430-59, 210430-6, 210430-60, 210430-61, 210430-62, 210430-63, 210430-64, 210430-65, 210430-66, 210430-67, 210430-68, 210430-69, 210430-7, 210430-70, 210430-71, 210430-72, 210430-73, 210430-74, 210430-75, 210430-76, 210430-77, 210430-78, 210430-79, 210430-8, 210430-80, 210430-81, 210430-82, 210430-83, 210430-84, 210430-85, 210430-86, 210430-87, 210430-88, 210430-89, 210430-9, 210430-90, 210430-91, 210430-92, 210430-93, 210430-94, 210430-95, , 210429-1, 210429-10, 210429-11, 210429-12, 210429-13, 210429-14, 210429-15, 210429-16, 210429-17, 210429-18, 210429-19, 210429-2, 210429-20, 210429-21, 210429-22, 210429-23, 210429-24, 210429-25, 210429-26, 210429-27, 210429-28, 210429-29, 210429-3, 210429-30, 210429-31, 210429-32, 210429-33, 210429-34, 210429-35, 210429-36, 210429-37, 210429-38, 210429-39, 210429-4, 210429-40, 210429-41, 210429-42, 210429-43, 210429-44, 210429-45, 210429-46, 210429-47, 210429-48, 210429-49, 210429-5, 210429-50, 210429-51, 210429-52, 210429-53, 210429-54, 210429-55, 210429-56, 210429-57, 210429-58, 210429-59, 210429-6, 210429-60, 210429-61, 210429-62, 210429-63, 210429-64, 210429-65, 210429-66, 210429-67, 210429-68, 210429-69, 210429-7, 210429-70, 210429-71, 210429-72, 210429-73, 210429-74, 210429-75, 210429-76, 210429-77, 210429-78, 210429-79, 210429-8, 210429-80, 210429-81, 210429-82, 210429-83, 210429-84, 210429-85, 210429-86, 210429-87, 210429-89, 210429-9, 210429-90, 210429-91, 210429-92, 210429-93, 210429-94, , 210427-10, 210427-11, 210427-12, 210427-13, 210427-14, 210427-15, 210427-16, 210427-17, 210427-18, 210427-19, 210427-20, 210427-21, 210427-22, 210427-23, 210427-24, 210427-25, 210427-26, 210427-27, 210427-28, 210427-29, 210427-30, 210427-31, 210427-32, 210427-33, 210427-34, 210427-35, 210427-36, 210427-37, 210427-38, 210427-39, 210427-40, 210427-41, 210427-42, 210427-43, 210427-44, 210427-6, 210427-7, 210427-8, 210427-9, , 209711-1, 209711-10, 209711-11, 209711-12, 209711-13, 209711-14, 209711-15, 209711-16, 209711-17, 209711-18, 209711-19, 209711-2, 209711-20, 209711-21, 209711-22, 209711-23, 209711-24, 209711-25, 209711-26, 209711-27, 209711-3, 209711-4, 209711-5, 209711-6, 209711-7, 209711-8, 209711-9, , 209704-1, 209704-14, 209704-5, 209704-6, 209704-7, , 209690-1, 209690-3, 209690-5, , 209558-19, 209558-21, 209558-26, 209558-29, 209558-3, , 209557-1, 209557-10, 209557-11, 209557-12, 209557-13, 209557-14, 209557-15, 209557-16, 209557-17, 209557-18, 209557-19, 209557-2, 209557-20, 209557-21, 209557-22, 209557-23, 209557-3, 209557-35, 209557-4, 209557-47, 209557-5, 209557-6, 209557-7, 209557-8, 209557-9, , 201249-1, 201249-2, 201249-3, 201249-4, 201249-5, , 201248-11, 201248-12, 201248-13, 201248-14, 201248-15, 201248-16, 201248-17, 201248-18, 201248-19, 201248-20, 201248-21, 201248-22, 201248-23, 201248-24, 201248-25, 201248-26, 201248-27, 201248-28, 201248-29, 201248-30, 201248-31, 201248-32, , 201247-1, 201247-10, 201247-11, 201247-12, 201247-13, 201247-14, 201247-15, 201247-16, 201247-17, 201247-18, 201247-19, 201247-2, 201247-20, 201247-21, 201247-22, 201247-23, 201247-24, 201247-25, 201247-26, 201247-27, 201247-28, 201247-29, 201247-3, 201247-30, 201247-31, 201247-32, 201247-33, 201247-34, 201247-35, 201247-36, 201247-37, 201247-38, 201247-39, 201247-4, 201247-40, 201247-41, 201247-42, 201247-43, 201247-44, 201247-45, 201247-46, 201247-47, 201247-48, 201247-49, 201247-5, 201247-50, 201247-6, 201247-7, 201247-8, 201247-9, , 201246-1, 201246-10, 201246-11, 201246-12, 201246-13, 201246-14, 201246-15, 201246-16, 201246-17, 201246-18, 201246-19, 201246-2, 201246-20, 201246-21, 201246-22, 201246-23, 201246-24, 201246-25, 201246-26, 201246-27, 201246-28, 201246-29, 201246-3, 201246-30, 201246-31, 201246-32, 201246-33, 201246-34, 201246-35, 201246-36, 201246-37, 201246-38, 201246-39, 201246-4, 201246-40, 201246-41, 201246-42, 201246-43, 201246-44, 201246-45, 201246-46, 201246-5, 201246-6, 201246-7, 201246-8, 201246-9, Expansion New Serial Numbers: 211579-27, 211579-3, 211579-39, 211579-44, 211579-47, 211579-48, 211579-60, 211579-92, 211579-93, 211579-94, 211579-96, 2B10867-1, 2B10867-101, 2B10867-102, 2B10867-103, 2B10867-105, 2B10867-107, 2B10867-108, 2B10867-11, 2B10867-110, 2B10867-14, 2B10867-15, 2B10867-16, 2B10867-17, 2B10867-18, 2B10867-19, 2B10867-2, 2B10867-20, 2B10867-21, 2B10867-22, 2B10867-23, 2B10867-25, 2B10867-26, 2B10867-27, 2B10867-28, 2B10867-29, 2B10867-3, 2B10867-31, 2B10867-32, 2B10867-33, 2B10867-34, 2B10867-36, 2B10867-37, 2B10867-38, 2B10867-40, 2B10867-41, 2B10867-42, 2B10867-44, 2B10867-45, 2B10867-48, 2B10867-49, 2B10867-5, 2B10867-50, 2B10867-52, 2B10867-53, 2B10867-54, 2B10867-57, 2B10867-58, 2B10867-6, 2B10867-62, 2B10867-64, 2B10867-65, 2B10867-70, 2B10867-71, 2B10867-72, 2B10867-73, 2B10867-74, 2B10867-75, 2B10867-76, 2B10867-77, 2B10867-79, 2B10867-80, 2B10867-81, 2B10867-82, 2B10867-83, 2B10867-84, 2B10867-86, 2B10867-87, 2B10867-88, 2B10867-89, 2B10867-9, 2B10867-91, 2B10867-92, 2B10867-93, 2B10867-97, 2B10867-98, 2B10867-99, 2B11089-1, 2B11089-10, 2B11089-100, 2B11089-101, 2B11089-102, 2B11089-103, 2B11089-105, 2B11089-108, 2B11089-109, 2B11089-11, 2B11089-110, 2B11089-111, 2B11089-112, 2B11089-113, 2B11089-114, 2B11089-115, 2B11089-116, 2B11089-117, 2B11089-118, 2B11089-119, 2B11089-14, 2B11089-15, 2B11089-16, 2B11089-18, 2B11089-19, 2B11089-2, 2B11089-21, 2B11089-24, 2B11089-25, 2B11089-26, 2B11089-27, 2B11089-29, 2B11089-3, 2B11089-30, 2B11089-32, 2B11089-33, 2B11089-34, 2B11089-35, 2B11089-36, 2B11089-37, 2B11089-38, 2B11089-39, 2B11089-4, 2B11089-40, 2B11089-41, 2B11089-42, 2B11089-43, 2B11089-44, 2B11089-45, 2B11089-46, 2B11089-48, 2B11089-49, 2B11089-5, 2B11089-50, 2B11089-51, 2B11089-52, 2B11089-53, 2B11089-54, 2B11089-55, 2B11089-57, 2B11089-58, 2B11089-59, 2B11089-6, 2B11089-60, 2B11089-62, 2B11089-64, 2B11089-65, 2B11089-66, 2B11089-67, 2B11089-68, 2B11089-69, 2B11089-7, 2B11089-70, 2B11089-71, 2B11089-73, 2B11089-74, 2B11089-75, 2B11089-76, 2B11089-79, 2B11089-8, 2B11089-80, 2B11089-89, 2B11089-92, 2B11089-93, 2B11089-94, 2B11089-95, 2B11089-96, 2B11089-97, 2B11089-98, 2B11089-99, 2B11635-1, 2B11635-10, 2B11635-11, 2B11635-12, 2B11635-14, 2B11635-15, 2B11635-17, 2B11635-18, 2B11635-19, 2B11635-2, 2B11635-22, 2B11635-24, 2B11635-25, 2B11635-27, 2B11635-28, 2B11635-29, 2B11635-3, 2B11635-30, 2B11635-31, 2B11635-32, 2B11635-34, 2B11635-36, 2B11635-38, 2B11635-39, 2B11635-4, 2B11635-40, 2B11635-41, 2B11635-49, 2B11635-5, 2B11635-50, 2B11635-52, 2B11635-53, 2B11635-54, 2B11635-55, 2B11635-56, 2B11635-57, 2B11635-58, 2B11635-59, 2B11635-60, 2B11635-67, 2B11663-10, 2B11663-11, 2B11663-12, 2B11663-13, 2B11663-14, 2B11663-15, 2B11663-21, 2B11663-24, 2B11663-25, 2B11663-26, 2B11663-27, 2B11663-28, 2B11663-29, 2B11663-3, 2B11663-30, 2B11663-31, 2B11663-32, 2B11663-35, 2B11663-36, 2B11663-37, 2B11663-38, 2B11663-39, 2B11663-4, 2B11663-41, 2B11663-42, 2B11663-43, 2B11663-44, 2B11663-46, 2B11663-47, 2B11663-48, 2B11663-49, 2B11663-5, 2B11663-50, 2B11663-51, 2B11663-56, 2B11663-57, 2B11663-58, 2B11663-59, 2B11663-6, 2B11663-60, 2B11663-61, 2B11663-62, 2B11663-63, 2B11663-64, 2B11663-65, 2B11663-66, 2B11663-67, 2B11663-69, 2B11663-7, 2B11663-71, 2B11663-73, 2B11663-74, 2B11663-75, 2B11663-76, 2B11663-78, 2B11663-8, 2B11663-82, 2B11663-88, 2B11663-90, 2B11667-1, 2B11667-11, 2B11667-12, 2B11667-13, 2B11667-14, 2B11667-15, 2B11667-16, 2B11667-17, 2B11667-18, 2B11667-19, 2B11667-2, 2B11667-25, 2B11667-26, 2B11667-27, 2B11667-28, 2B11667-3, 2B11667-31, 2B11667-33, 2B11667-34, 2B11667-35, 2B11667-36, 2B11667-37, 2B11667-38, 2B11667-39, 2B11667-40, 2B11667-43, 2B11667-44, 2B11667-45, 2B11667-46, 2B11667-48, 2B11667-49, 2B11667-5, 2B11667-50, 2B11667-51, 2B11667-52, 2B11667-54, 2B11667-56, 2B11667-58, 2B11667-59, 2B11667-60, 2B11667-61, 2B11667-64, 2B11667-65, 2B11667-66, 2B11667-67, 2B11667-69, 2B11667-7, 2B11667-70, 2B11667-71, 2B11667-72, 2B11667-73, 2B11667-74, 2B11667-75, 2B11667-76, 2B11667-77, 2B11667-79, 2B11667-82, 2B11667-86, 2B11667-88, 2B11667-89, 2B11667-90, 2B11667-91, 2B11667-92; 2. FR4A-TRL-B0, Serial Numbers: 2B10867-39
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