Reported Feb 14, 2018 · Ongoing
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
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, 15cm, Material CA15L1
- Lot codes and dates
84 of 84 codes
UDI 10884521189539Lots S5LG002PXS5MG004PXS5MG009PXS5MG010PXS5MG013PXS5MG017PXS5MG019PXS6AG002XS6AG003XS6AG006XS6AG009XS6AG010XS6BG001XS6BG006XS6BG012XS6BG013XS6BG014PXS6CG001XS6CG004XS6CG006XS6CG007XS6CG009XS6CG013XS6CG018XS6CG019XS6DG001XS6DG003XS6DG006XS6DG008XS6DG009XS6EG002XS6EG003XS6EG005XS6EG007XS6EG010XS6FG002XS6FG003XS6FG004XS6FG009XS6GG004XS6GG005XS6GG006XS6GG008XS6GG009XS6GG011XS6GG012XS6GG015XS6HG002XS6HG010XS6HG011XS6HG013XS6KG001XS6KG004PRXS6KG004PXS6KG007XS6KG008XS6KG010XS6KG014XS6KG015X
- 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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