Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-1433-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: March 26, 2021

Date Posted: April 28, 2021

Recall Number: Z-1433-2021

Event ID: 87671

Reason for Recall:

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

Status: Terminated

Product Quantity: 23 units

Code Information:

Lot: 26147100, 26154112

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

Voluntary or Mandated:

Voluntary: Firm initiated