FDA Medical Device Recalls (openFDA)
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: 720185-01, 72404156
- Recall number
- Z-1433-2021
- Recalling firm
- Boston Scientific Corporation
- 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
- Status
- Terminated
- Initiated
- 2021-03-26
- Posted
- not on file
- Terminated
- 2024-03-04
- Reason
- An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 23 units
- Distribution
- Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal
- Lot, serial or model codes
- Lot: 26147100, 26154112
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JCW
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28