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Open, Classified

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1

FDA Recall Z-0558-2018 · Posted None

Recalling FirmCovidien LLC
Recall StatusOpen, Classified
Product CodeNEY
Date Initiated2017-08-07

Reason for Recall

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.

Firm Action

All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.

Root Cause

Device Design

Distribution Pattern

Nationwide including PR, Canada, China

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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