Recall of Covidien Endo GIA™ Black Radial Reload with Tri-Staple™ Technology (Lot no. N6L0351X) due to device cartridge disengagement issue

Covidien Pte Ltd would like to inform healthcare professionals that Medtronic, the distributor is recalling Covidien Endo GIA™ Black Radial Reload with Tri-Staple™ Technology (Lot no. N6L0351X) following reports of device cartridge disengagement during use due to manufacturing error. The use of the affected products may result in the need for retrieval of a foreign body and/or incomplete deployment of the unit’s staples resulting in a non-functional staple closure. No patient injury or impairment has been reported in relation to this issue. Healthcare professionals are advised to quarantine and return the affected device and its corresponding lot to their Medtronic representative. 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 ↗ (opens in new tab) 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.