Reported Feb 14, 2018 · Ongoing
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
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 Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
- Lot codes and dates
- UDI 10884521189546
- Lot codes
S5LG003PXS5MG016PXS5MG018PXS6AG004XS6AG005XS6AG007XS6BG004XS6BG011XS6BG015PXS6BG017XS6CG002XS6CG008XS6CG014XS6CG015XS6CG016XS6DG002XS6DG005XS6DG007XS6DG010XS6EG004XS6EG006XS6EG008XS6FG005XS6FG008XS6GG007XS6GG010XS6HG001XS6HG003PXS6HG008PXS6HG009PXS6HG012XS6JG001XS6KG003XS6KG005PRXS6KG005PXS6KG009XS6KG016XS6LG002XS6MG003XS6MG018XS7AG003XS7BG012PCXS7CG004XS7CG006XS7CG008PCXS7CG010PCXS7CG017XS7DG002XS7DG005XS7EG006XS7FG010PX
- Amount recalled
- N/A
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
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.
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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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