—#194629

Product

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

FDA product code: HIH — Hysteroscope (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K031787, K132015
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain

Timeline

Recall initiated: 2022-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.