TruClear recallZ-1467-2022 · Covidien Llc · initiated Jun 7, 2022
Class II Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1467-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 7, 2022
- Recalling firm
- Covidien Llc
- Quantity
- 33 units
- Product code
- HIH
- FDA submissions
- K031787, K132015
- Distribution
- AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
Product description
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TruClear 7209808Covidien LP · HYSTEROSCOPE (AND ACCESSORIES)1 recall32 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K031787, K132015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TruClear 7209208Covidien LP · HYSTEROSCOPE (AND ACCESSORIES)7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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