Recall of all sizes and lots of Venovo™ Venous Stent System due to proximal end of stent not expanding immediately upon deployment

A Dear Healthcare Professional Letter has been issued by Bard Singapore Ptd Ltd to inform healthcare professionals of the recall of all sizes and lots of the Venovo™ Venous Stent System, as a follow up to an earlier communication issued on 3 February 2021. Reports of various sizes of the product indicating that the proximal stent end did not immediately expand upon deployment but remained connected to the stent cushion on the delivery system have been received. Over-manipulation or forcing the catheter delivery system in attempts to assist the stent's expansion could potentially prolong the procedure, damage or deform the stent, or cause potential vascular injury, hemodynamic disruption affecting the blood flow and/or a thrombotic event. In cases where the stent self-expanded, there is no incremental risk of harm. Healthcare professionals are advised to immediately quarantine and return all the affected products. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

4 Jun 2021

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.