Stimwave Technologies Inc: Medical Device Recall in 2020 - (Recall #: Z-2933-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 15, 2020

Date Posted: September 9, 2020

Recall Number: Z-2933-2020

Event ID: 86115

Reason for Recall:

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

Status: Ongoing

Product Quantity: 13 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated