FDA Device recall Z-1433-2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline by Boston Scientific, citing an AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1433-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-26 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, UT |
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
Reason
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Identifiers
| code_info | Lot: 26147100, 26154112 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1433-2021%22
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