The Recall Desk

FDA (Devices) recall action 64875

American Medical Systems, Inc. recalled 2 products on 2013-05-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-05-22
Critical
0
Units
682

Why these products were recalled

American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2013-05-22

    American Medical Systems Recalls AMS 800 Urinary Control System Components

    American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2013-05-22

    AMS 800 Urinary Control System Components Recalled for Release Criteria Failures

    American Medical Systems is recalling 77 AMS 800 Control Pumps and Pressure-Regulating Balloons because they were released without meeting final product release criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Distribution
    43 states