Emprint Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone (2019-03-28)

Starting date:

March 28, 2019

Posting date:

May 3, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69812

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

Emprint Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone

Reason

Medtronic is advising customers that we will be updating the Instructions for Use (IFUs) to include important information identified through our investigation of detached antenna tips. Tip detachment during a procedure can lead to a retained foreign body, which creates risk for infection.

Affected products