The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled… — Class II medical device recall Z-1433-2021
Terminated recall by Boston Scientific Corporation, reported 2021-04-28, distributed in AR, AZ, CO, FL, GA, IA, MI, MO…. An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir wi
| Recall number | Z-1433-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-04-16 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2024-03-04 |
| Distributed | AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, UT |
| Countries outside the US | BE, FR, PT |
| Quantity | 23 units |
| Reason classes | labeling |
| Lot numbers | 26147100, 26154112 |
| Model numbers | 720185-01, 72404156 |
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 for recall
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1433-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.