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Recall Observatory FDA recall evidence

Device product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

Z-0559-2018

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-0559-2018

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 10884521706590, Lot codes: S6MG006PX,S6MG009PX,S6MG013PX,S6MG020PX,S7AG011X,S7AG012X,S7BG008X,S7CG003X,S7DG003X,S7DG009X,S7FG001X,S7FG002X,S7FG005X,S7FG008X

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.