Bard Caliber (CL3030) Inflation Device Product Usage:... (PEROUSE MEDICAL) – additional instructions for use due t... (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
PEROUSE MEDICAL
Lot Codes / Batch Numbers
All lot numbers beginning with Numbers: 1403, 1404, 1405, 1406, 1407
Products Sold
All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407
PEROUSE MEDICAL is recalling Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during due to Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or de. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 22, 2026