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Terminated

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

FDA Recall Z-0876-2015 · Posted 2014-12-29

Recalling FirmPEROUSE MEDICAL
Recall StatusTerminated
Product CodeMAV
Date Initiated2014-10-06
Date Terminated2017-03-24
Product Quantity24821 units

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

Firm Action

Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of AZ and CO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042449DOLPHIN INFLATION DEVICESedat S.A. · 2005-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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