Recall Z-1433-2021 ยท JCW Prosthesis, Penis, Inflatable
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, th
| Date | Mar 26, 2021 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.