Class 2 Device Recall Covidien TruClear hysteroscopic tissue removal system

• Date Initiated by Firm: June 07, 2022
• Create Date: July 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1467-2022
• Recall Event ID: 90519
• 510(K)Number: K031787 K132015
• Product Classification: Hysteroscope (and accessories) - Product Code HIH
• Product: TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
• Code Information: UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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: rs.covidienfeedbackcustomerservice@medtronic.com b. Product purchased through distributor: rs.gmbfcamitg@medtronic.com " 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 rs.covidienfeedbackcustomerservice@medtronic.com " If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.
• Quantity in Commerce: 33 units
• Distribution: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
• 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 = HIH