Reported Dec 26, 2018 · Ongoing
Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous,…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
- Lot codes and dates
- GTIN Number - 10884521706590 Lot Numbers-
S7HG001PXS7HG004KXS7HG010KXS7HG011KXS7HG012KXS7HG030LXS7HG031LXS7HG035LXS7HG039LXS7HG042LXS7HG043XS7JG006XS7JG010XS7JG013XS7JG014XS7KG008LXS7KG009LXS7KG010LXS7KG041XS7KG043XS7LG003XS7LG004XS7MG003XS7MG004LXS7MG017PXS7MG029XS8BG001XS8BG002XS8BG006XS8CG001XS8CG008LXS8CG009XS8CG018XS8CG023XS8DG019LXS8DG020LXS8DG021LXS8DG022LXS8DG023XS8DG025X
- GTIN Number - 10884521706590 Lot Numbers-
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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