Covidien recalls Emprint Long Percutaneous Antenna with Thermosphere Technology (Material CA30L2) due to risk of ceramic tip remaining in patient after surgery. 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 a type of surgical antenna used for tissue ablation because the ceramic tip can detach and stay inside the patient after treatment. This poses a serious risk of internal injury if the tip remains in the body.
After surgery, the ceramic tip of the antenna can become detached from the needle shaft. If this happens, the tip may remain inside the patient, causing potential internal injury or complications.
Surgical patients who received this specific antenna during procedures. Medical staff using the device for liver tumor ablation are most at risk.
Check for the product name 'Emprint Long Percutaneous Antenna with Thermosphere Technology' and lot numbers listed in the recall notice: S7HG007KX through S8EG004X.
Immediately stop using the recalled antenna if you have it. Do not attempt to repair or continue using it.
The ceramic tip can detach from the needle shaft after surgery, potentially remaining inside the patient and causing injury.
Lot numbers S7HG007KX through S8EG004X as listed in the recall notice.
The recall does not provide a fix; the remedy is to stop using the device immediately.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0625-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0625-2019 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.
