Recall of Medtronic StrataMR™ Adjustable Valves & Shunts with potential underdrainage issue

Medtronic International Limited would like to inform healthcare professionals of the voluntary recall of all unused units of Medtronic StrataMR™ adjustable valves & shunts due to the potential for underdrainage of cerebrospinal fluid. Medtronic’s investigation has determined an increase in the occurrence rate of StrataMR™ complaints, related to incorrect flow or level change in the month of January 2017. Healthcare professionals are advised to return all unused affected devices to Medtronic, and to refer to the value adjustment instructions in the Information For Use for the continued care of patients already implanted with the affected devices. 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.