medical Class II Updated 2021-04-28

Boston Scientific Corporation recalls The AMS 700 Inflatable Penile Prosthesis is a closed fluid-f

Recalled Product

The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156


Hazard / Issue

An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.

Issued by

FDA

Affected States: AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, UT
Lot/Code Info: Lot: 26147100, 26154112
View official government recall

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