Covidien recalls Emprint Short Percutaneous Antenna with Thermosphere Technology (Material CA15L2) due to risk of ceramic tip remaining in patient after ablation. Affected units have specific lot numbers.
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Covidien is recalling its Emprint Short Percutaneous Antenna with Thermosphere Technology (Material CA15L2) because the ceramic tip can detach from the needle shaft after treatment, potentially leaving it inside the patient. This is a serious medical device hazard that requires immediate attention.
After ablation treatment, the ceramic tip of the antenna can become detached from the needle shaft. If the tip remains inside the patient, it could cause internal injury or infection. This is a serious medical hazard that requires immediate removal.
Healthcare professionals using this device for liver tumor ablation procedures are most at risk. Patients who have undergone the procedure with this specific model may need evaluation.
Check for the product name 'Emprint Short Percutaneous Antenna with Thermosphere Technology' and the specific lot numbers listed in the recall notice. The device is used for liver tumor ablation procedures.
Immediately stop using the recalled device as it may remain inside the patient after treatment.
The ceramic tip of the antenna can detach from the needle shaft after ablation, potentially leaving it inside the patient.
The affected lot numbers are listed in the recall notice: S7HG002X, S7HG003X, S7HG005KX, and other specific codes.
Yes, if you have had the procedure with this device, contact your doctor immediately to check for the tip remaining inside you.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0626-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0626-2019 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.
