Class 2 Device Recall StimQ Peripheral Nerve Stimulator System

• Date Initiated by Firm: July 15, 2020
• Date Posted: September 02, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2931-2020
• Recall Event ID: 86115
• 510(K)Number: K152178 K171366
• Product Classification: Stimulator, peripheral nerve, implanted (pain relief) - Product Code GZF
• 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.
• Code Information: FR4A-SPR-BO-US, Serial Numbers: 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, 210431-93
• Recalling Firm/ Manufacturer: Stimwave Technologies Inc; 1310 Park Central Blvd S; Pompano Beach FL 33064-2217
• For Additional Information Contact: 800-965-5134
• Manufacturer Reason for Recall: The product contains a non-functional component not referenced in product labeling.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GZF; 510(K)s with Product Code = GZF