Reported Feb 14, 2018 · Ongoing
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
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, 30cm, Material CA30L1
- Lot codes and dates
- UDI 10884521189553
- Lot codes
S5LG004PXS6AG001XS6BG002XS6BG005XS6BG016PXS6CG003XS6CG005XS6CG017XS6DG004XS6EG001XS6FG001XS6FG006XS6FG010XS6KG002XS6KG006PRXS6KG006PXS6LG004XS6MG002XS7CG001PCXS7CG011PCXS7CG015CXS7EG001XS7EG003XS7FG011PX
- 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.
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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