Lotus Valve Systems (2017-02-23)

Starting date:

February 23, 2017

Posting date:

March 16, 2017

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-62656

• Reason
• Affected products

Affected Products

A. Lotus Valve System - 23mm Implantable Valve
B. Lotus Valve System - 27mm Implantable Valve
C. Lotus Valve System - 25mm Implantable Valve

Reason

Boston Scientific Corporation has recently received a higher than anticipated number of reports of early pin release prior to locking the valve in the final position. If this occurs, the valve is unable to be fully locked, which requires the valve to be resheated and removed from the patient prolonging the procedure.

Affected products