Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0560-2018 — Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1

U.S. FDA — Device Enforcement · United States · 2017-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0560-2018
Date of alert
2017-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521189553
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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