Reported Sep 9, 2020 · Ongoing

StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural…

Stimwave Technologies Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stimwave Technologies Inc · 1310 Park Central Blvd S · Pompano Beach, FL · 33064-2217

Is this the product you have?

StimQ Peripheral Nerve Stimulator System (PNS)
Model FR4A-TRL-AO US - Product Usageis 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

Lot codes and dates: Serial Numbers
1,228 of 1,228 codes
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
additional serial numbers included
324 of 324 codes
2B11665-67
2B11665-68
2B11664-72
210425-69
210425-70
2B11664-48
2B11664-75
2B11664-76
2B11664-88
2B11665-12
2B11665-29
2B11665-32
2B11665-34
2B11665-35
2B11665-36
2B11665-7
2B11807-22
2B11807-23
2B11808-69
2B11808-7
2B11808-71
2B11808-72
2B11808-70
2B11664-71
210425-41
2B11808-13
2B11664-87
211576-62
2B11664-33
2B11665-78
2B11665-81
2B11665-84
2B11665-85
2B11665-9
2B11807-42
2B11807-43
2B11808-17
2B11808-53
2B11876-64
2B11808-12
210425-68
2B11808-86
2B11808-49
211576-40
211576-50
211576-56
2B11876-41
2B11876-31
210425-52
211576-74
2B11664-1
2B11665-80
2B11808-80
2B11665-13
2B11807-12
2B11807-8
2B11876-35
2B11876-36
2B11876-37
2B11876-38
additional serial numbers added
303 of 303 codes
2B11876-54
2B11876-55
2B11876-58
2B11876-59
2B11876-6
2B11876-60
2B11876-64
2B11876-67
2B11876-68
2B11876-69
2B11876-7
2B11876-70
2B11876-73
2B11876-74
2B11876-75
2B11876-76
2B11876-78
2B11876-8
2B11876-81
2B11876-82
2B11876-83
2B11876-84
2B11876-85
2B11876-86
2B11876-87
2B11876-91
2B11876-92
2B11876-93
2B11878-1
2B11878-4
2B11878-5
2B11878-6
2B11878-7
2B11878-8
2B11878-85
2B11878-87
2B11878-88
2B11878-9
211569-46
211569-6
211569-64
2B11768-1
2B11768-11
2B11768-12
2B11768-13
2B11768-14
2B11768-15
2B11768-16
2B11768-17
2B11768-18
2B11768-19
2B11768-2
2B11768-20
2B11768-21
2B11768-22
2B11768-23
2B11768-24
2B11768-25
2B11768-27
2B11768-28
Amount recalled: 1550 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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