Ogos 2021 : Urgent MEDICAL DEVICE FIELD CORRECTION (Event ID: Cordis2020720) : Cordis SUPER TORQUE®MB Angiographic Catheter - Correction related to labeling of a specific subset of angiographic catheters

Urgent MEDICAL DEVICE FIELD CORRECTION (Event ID: Cordis2020720) : Cordis SUPER TORQUE®MB Angiographic Catheter - Correction related to labeling of a specific subset of angiographic catheters

 

Affected Medical Device : Cordis SUPER TORQUE®MB Angiographic Catheters (with MarkerBands)

 

MDA Reference Number : MDA/FCA/2021-P121

 

MDA Registration Number : GD54232306417

 

Decription : Cordis is initiating this FCA to inform customers that the SUPERTORQUE®MB Angiographic Catheter (withMarkerBands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker bandmovement or dislodgement.

 

Local Establishment Contact Detail :

Elizabeth Pugh
Regulatory Affairs Consultant
EMERGO by UL
Level 16, 1 Sentral, Jalan Stesen Sentral 5, KL Sentral, 50470, Kuala Lumpur, Malaysia
T: +60.3.2092.9484

Email : SEAsiaVigilance@ul.com

 

 A copy of FSN.