Recall of selected serial numbers of AMS 700™ with MS Pump™ at risk of initial activation issues

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals of a voluntary recall of selected serial numbers of unused AMS 700 Inflatable Penile Prosthesis with MS (Momentary Squeeze) Pump following an increase in complaints related to the initial activation of the device. This issue typically occurred within the first 2 months after an AMS 700 implant procedure and resulted in inability or difficulty in activating the implanted pump, even after exhaustive troubleshooting and patient training. The root cause has been attributed to one mold cavity used in the production of the silicone MS Pump valve block component. An internal investigation has estimated up to 2% of all MS Pumps to be affected and at risk for initial activation issues. The most common and most severe health consequence that could result from the described pump failure would be a pump replacement procedure and the risks associated with anaesthesia and surgery. Healthcare professionals are advised to return unused affected products to Boston Scientific and to take into consideration this notification when managing their patients who are suspected to have an affected device. No action is required for normally functioning devices. Please refer to the letter for details. Published: 15 Oct 2020

Dear Healthcare Professional Letters