Covidien recalls TruClear Hysteroscopic Tissue Removal System Control Units with electrical component failure risk. Affected units have specific serial numbers. Stop using immediately to prevent loss of function during procedures.
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.
Covidien is recalling certain TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure that can cause the device to stop working when used with handpieces and foot switches. This could lead to incomplete tissue removal during medical procedures.
The control unit has an electrical component that can fail, causing the device to lose function when paired with handpieces and foot switches. This means the system might not work properly during procedures, potentially leading to incomplete tissue removal.
Healthcare providers using the TruClear system for intrauterine tissue removal are most at risk. Patients undergoing procedures with this device may be affected if the control unit fails during treatment.
Check for serial numbers starting with YF1120 through YF1182. The product was sold with model number 7209808 and UDI-Device Identifier 10884521749931.
Discontinue use of the control unit if it has a serial number from YF1120 to YF1182.
The model number is 7209808.
Serial numbers from YF1120 to YF1182.
The recall record does not mention a remedy or replacement option.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1467-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1467-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.