The National Consumer Commission (NCC) informs consumers and healthcare professionals of a recall of certain Boston Scientific Direxion and Direxion HI-FLO Torqueable Microcatheters. The recall affects 199 units distributed to healthcare facilities across South Africa. 

According to the supplier, the recall is due to a manufacturing issue that may cause difficulty removing the microcatheter from its carrier hoop or advancing and withdrawing it through a guide catheter. Increased resistance during these processes may damage the device. The affected products are single-lumen, multipurpose microcatheters used by healthcare professionals to access treatment sites in the peripheral vasculature during medical procedures. 

The supplier further submitted that the most serious potential harm from a dysfunctional microcatheter is life-threatening embolism, which is assessed as a remote likelihood of occurrence. 

The affected products were distributed to healthcare facilities, including Diagnostic Radiological Services, Groote Schuur Hospital, Netcare facilities, Life Wilgers Hospital, Life Peglerae Hospital, Capital Radiology and other healthcare providers across the country. 

Healthcare professionals are advised to immediately discontinue the use of affected products, remove them from inventory and segregate them in a secure location pending return to Boston Scientific. Furthermore, they should consult the supplier’s recall notice to verify the affected product and lot numbers. 

Consumers and healthcare professionals with questions or concerns relating to this recall may contact the NCC at ProductRecall@thencc.org.za. 

 Ends 

Issued by: National Consumer Commission (NCC) 2 

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