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

Recall Summary The Emprint Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone medical device is being recalled in Canada because of a safety issue with the device. This recall affects all units of this device that were distributed across Canada. The FDA classified this as a Class I recall, which is the most serious type.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-05-03

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/338baf9a-da53-47e5-b2d8-ba0aa9c59134