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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien TruClear hysteroscopic tissue removal system

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  Class 2 Device Recall Covidien TruClear hysteroscopic tissue removal system see related information
Date Initiated by Firm June 07, 2022
Create Date July 26, 2022
Recall Status1 Open3, 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 2		 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 and Original Applicant = SMITH & NEPHEW, INC.
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