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Recall Observatory FDA recall evidence

Device product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

Z-0557-2018

August 07, 2017

Class II

Product summary

Firm
Covidien LLC
Event
Event 79075
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0557-2018

Official wording

Reason: 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.

Code information: UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X

Distribution pattern: Nationwide including PR, Canada, China

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.