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Mitraclip triclip g4 delivery systems
Official notice
23 Sept 2022
Last checked
23 Sept 2022
An official Health Canada notice concerns Mitraclip triclip g4 delivery systems. 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 Published 2022-09-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64557
Official notice
2022-09-23
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Abbott Vascular, Mitraclip Triclip G4 Delivery.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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