Prosthesis, Penis, Inflatable

TENACIO Pump with InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

TENACIO Pump without InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

CX Preconnect with TENACIO Pump without InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

LGX Preconnect with TENACIO Pump without InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

CX Preconnect with TENACIO Pump with InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

CXR Preconnect with TENACIO Pump with InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

LGX Preconnect with TENACIO Pump with InhibiZone;

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

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 physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.

AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dys

A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.

AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850.

AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.