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MITRACLIP CLIP DELIVERY SYSTEM (2016-02-08)
- Starting date:
- February 8, 2016
- Posting date:
- February 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57196
Affected Products
MITRACLIP CLIP DELIVERY SYSTEM
Reason
Abbott Vascular (AV) has recently received reports where the user attempted implanting a MitraClip, but the clip could not be detached from the delivery system due to a mandrel fracture. A mandrel fracture may occur if tension is present on the mandrel when turning the actuator knob to deploy the clip. Tension is present if the arm positioner is on the "closed" side of neutral, as opposed to being in the neutral position during clip deployment. The Field Safety Notice (FSN) is to alert users and provide an alternative deployment sequence that will ensure tension is not present in the system.
Affected products
MITRACLIP CLIP DELIVERY SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CDS0201
Companies
- Manufacturer
-
Evalve, Inc. DBA Abbott Vascular Inc.
4045 CAMPBELL AVENUE
MENLO PARK
94025
California
UNITED STATES