PEROUSE MEDICAL: Medical Device Recall in 2015 - (Recall #: Z-0877-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 6, 2014

Date Posted: January 7, 2015

Recall Number: Z-0877-2015

Event ID: 69879

Reason for Recall:

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

Status: Terminated

Product Quantity: 2184 units

Code Information:

Batch numbers: 4041354/4062650/4072586

Distribution Pattern:

US Nationwide Distribution in the states of AZ and CO.

Voluntary or Mandated:

Voluntary: Firm initiated