Home › Device types › JCW
Prosthesis, Penis, Inflatable
FDA product code JCW · Class 3 · Gastroenterology, Urology
150
Registered devices
2,834
Adverse events
19
Recalls
0
510(k) clearances
Devices with this code
AMS 700 CX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CX TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 LGX™ TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CXR MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CX TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CXR TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONRear Tip Extender — BOSTON SCIENTIFIC CORPORATIONAMS 700 CX — BOSTON SCIENTIFIC CORPORATIONAMS 700 CX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CXR — BOSTON SCIENTIFIC CORPORATIONRear Tip Extender — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CXR TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CX TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CX TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 LGX™ TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 LGX™ TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CXR RTE Kit — BOSTON SCIENTIFIC CORPORATIONAMS 700™ TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 CX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CXR TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700 LGX MS Pump — BOSTON SCIENTIFIC CORPORATIONAMS 700™ CXR TENACIO™ Pump — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2025-09-11 | Boston Scientific Corporation | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| 2021-03-26 | Boston Scientific Corporation | An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. |
| 2020-09-24 | Boston Scientific Corporation | The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the ph |
| 2019-12-17 | Boston Scientific Corporation | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone. |
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