Barrx 360 Express RFA Balloon Catheter (2018-02-08)

Starting date:

February 8, 2018

Posting date:

February 22, 2018

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-66032

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  Reason
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  Affected products

Affected products

Barrx 360 Express RFA Balloon Catheter

Reason

Medtronic has become aware of two situations where use of the Barrx 360 Express RFA Balloon Catheter in a manner which is inconsistent with the instructions for use (abnormal use), resulted in adverse events, including three esophageal perforations and a 15% esophageal stricture rate.

Affected products