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Recall Observatory FDA recall evidence

Device product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1

Z-0556-2018

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-0556-2018

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 10884521189539, Lots S5LG002PX,S5MG004PX,S5MG009PX,S5MG010PX,S5MG013PX,S5MG017PX,S5MG019PX,S6AG002X,S6AG003X,S6AG006X,S6AG009X,S6AG010X,S6BG001X,S6BG006X,S6BG012X,S6BG013X,S6BG014PX,S6CG001X,S6CG004X,S6CG006X,S6CG007X,S6CG009X,S6CG013X,S6CG018X,S6CG019X,S6DG001X,S6DG003X,S6DG006X,S6DG008X,S6DG009X,S6EG002X,S6EG003X,S6EG005X,S6EG007X,S6EG010X,S6FG002X,S6FG003X,S6FG004X,S6FG009X,S6GG004X,S6GG005X,S6GG006X,S6GG008X,S6GG009X,S6GG011X,S6GG012X,S6GG015X,S6HG002X,S6HG010X,S6HG011X,S6HG013X,S6KG001X,S6KG004PRX,S6KG004PX,S6KG007X,S6KG008X,S6KG010X,S6KG014X,S6KG015X,S6KG017X,S6LG001X,S6LG003X,S6LG005X,S6LG006X,S6LG008X,S6LG009X,S6LG010X,S6MG001X,S6MG004X,S6MG017X,S7AG004X,S7BG002X,S7BG011PCX,S7CG009PCX,S7CG012PCX,S7CG016X,S7DG001X,S7DG006X,S7EG002X,S7EG004X,S7EG005X,S7FG009PX,S7GG001X

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.