Dear Healthcare Professional Letters
Recall of all sizes and lots of Venovo™ Venous Stent System due to proximal end of stent not expanding immediately upon deployment
Audiences
Healthcare professional
Industry member
Product type
Medical devices
2 June 2021
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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.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.