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Recall Observatory FDA recall evidence

Device product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1

Z-0560-2018

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-0560-2018

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 10884521189553, Lot codes: S5LG004PX,S6AG001X,S6BG002X,S6BG005X,S6BG016PX,S6CG003X,S6CG005X,S6CG017X,S6DG004X,S6EG001X,S6FG001X,S6FG006X,S6FG010X,S6KG002X,S6KG006PRX,S6KG006PX,S6LG004X,S6MG002X,S7CG001PCX,S7CG011PCX,S7CG015CX,S7EG001X,S7EG003X,S7FG011PX

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.