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[Recalled] Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 — The firm received consumer reports of the ceramic trocar tip of the Emprint abl… | FDA 2017-08-07

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCovidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
Brand / manufacturerCovidien LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0560-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date07 August 2017
EAN / barcode10884521189553

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Covidien LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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