—#186737

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

FDA product code: JCW — Prosthesis, Penis, Inflatable
Device class: Class 3
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot: 26147100, 26154112

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

On 3/25/2021, BCS issued an Urgent Medical Device Removal notice via letter to customers notifying them certain serial numbers of AMS 700 Reservoirs may have been incorrectly labeled.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal

Timeline

Recall initiated: 2021-03-26
Terminated: 2024-03-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.