Mitraclip/Triclip G4 Delivery Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Mitraclip G4 Clip Delivery System, Nt |
More than 10 numbers, contact manufacturer. |
CDS0701-NT |
Triclip G4 Delivery System |
More than 10 numbers, contact manufacturer. |
TCDS0305-XTW |
Mitraclip G4 Clip Delivery System, Ntw |
More than 10 numbers, contact manufacturer. |
CDS0701-NTW |
Mitraclip G4 Clip Delivery System, Xtw |
More than 10 numbers, contact manufacturer. |
CDS0701-XTW |
Mitraclip G4 Clip Delivery System, Xt |
More than 10 numbers, contact manufacturer. |
CDS0701-XT |
Issue
Abbott has observed an increase in complaints regarding clip locking malfunctions. Abbott is bringing awareness and taking action to emphasize the relevant steps of the instructions for use (IFU) to aid in optimal function of the clip locking mechanism. Current inventory of product may be used with the guidance described in the attached materials. There is no need to return any product to abbott. no further action is needed for patients who have had clips previously implanted. The increased rate of reports is for clips failing to "establish final arm angle" (EFAA) and for events of "clip opening while locked" (COWL).
Recall start date: September 8, 2022
Additional information
Details
Abbott Vascular
3200 Lakeside Drive, Santa Clara, California, United States, 95054-2807
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