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
Enforcement
- Recall Number
- Z-1433-2021
- Event ID
- 87671
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 28, 2021
- Initiation Date
- March 26, 2021
- Classification Date
- April 16, 2021
- Termination Date
- March 4, 2024
- Address
- 100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States
Description
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
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Lot: 26147100, 26154112
Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal
23 units