Device, Incontinence, Mechanical/Hydraulic
FDA product code EZY · Class III (high risk) · 21 CFR 876.5280 · Gastroenterology, Urology
PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
0510(k) clearances
2PMA approvals
7recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0531-2025 Class II | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024)… | Boston Scientific Corporation | 10/28/2024Open, Classified |
| Z-0530-2025 Class II | AMS Artificial Urinary Sphincter Control PumpPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024)… | Boston Scientific Corporation | 10/28/2024Open, Classified |
| Z-0458-2022 Class II | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the… | Uromedica Inc. | 11/22/2021Terminated |
| Z-2442-2019 Class II | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. | Boston Scientific Corporation | 07/19/2019Terminated |
| Z-1280-2013 Class II | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat…American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control… | American Medical Systems, Inc. | 03/01/2013Terminated |
| Z-1279-2013 Class II | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat…American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control… | American Medical Systems, Inc. | 03/01/2013Terminated |
| Z-2669-2011 | AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only )…American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps.… | American Medical Systems, Inc. | 05/09/2011Terminated |