PEROUSE MEDICAL

3 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Diagnostic Equipment

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND

Class I - Dangerous

Complaints regarding broken blister.

Apr 5, 2017 Other Medical Devices View Details →

Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

Class I - Dangerous

Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

Oct 6, 2014 Diagnostic Equipment Nationwide View Details →

Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

Class I - Dangerous

Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

Oct 6, 2014 Diagnostic Equipment Nationwide View Details →

Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

Class I - Dangerous

Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.

May 10, 2012 Diagnostic Equipment View Details →