Boston Scientific Corporation 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: Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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:
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot: 26147100, 26154112
Products Sold
Lot: 26147100, 26154112
Boston Scientific Corporation is recalling The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The sys due to An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, UT
Page updated: Jan 10, 2026