TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: "Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility. " Return all affected product in your inventory to Medtronic. a. Product purchased directly from Medtronic: [email protected] b. Product purchased through distributor: [email protected] " Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Complete the enclosed Customer Confirmation Form and email it to [email protected] " If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.