Thermablate Disposable Cartridge and Thermablate Treatment Control Unit Kit (2018-07-18)

Starting date:

July 18, 2018

Posting date:

August 31, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67610

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  Reason
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  Affected products

Affected products

A. Thermablate Disposable Cartridge

B. Thermablate Treatment Control Unit Kit

Reason

The Field Safety Notification (FSN) was issued to inform Thermablate users of updated contraindications and warnings to the Thermablate IFU in addition to providing the user with safety and effectiveness data. Idoman-med does not intend to recall product from the field as there are no defective products.

Affected products