PEROUSE MEDICAL: Medical Device Recall in 2015 - (Recall #: Z-0876-2015)

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:

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

Product Classification:

Class II

Date Initiated: October 6, 2014

Date Posted: January 7, 2015

Recall Number: Z-0876-2015

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: 24821 units

Code Information:

All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407

Distribution Pattern:

US Nationwide Distribution in the states of AZ and CO.

Voluntary or Mandated:

Voluntary: Firm initiated