Syringe, Balloon Inflation, Exempt

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL

Inflation device handle may detach from the syringe during procedure.

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

basixTOUCH Inflation Device, REF: IN8140/A

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

BlueFIRE Inflation Device, REF: IN10140

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

basixSKY Inflation Device, REF: SKY1802

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.