StentBoost - Software (2019-03-04)

Starting date:

March 4, 2019

Posting date:

March 22, 2019

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-69380

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  Reason
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  Affected products

Affected Products

StentBoost - Software

Reason

In the intended use of the instructions for use the following claim is made: StentBoost assists in stent selection by providing a measurement tool which the operator can use to measure the lesion. However, StentBoost cannot assist in the selection of a stent, because the measurement function is only available after placement of the stent. Please note that the primary use of StentBoost for enhanced stent visualization is not affected. Correct intended use is added to the section "advice on actions by customer/user." This issue does not pose any risk to health of patients, users or bystanders.

Affected products