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U.S. Department of Health and Human Services

Class 2 Device Recall Bard

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  Class 2 Device Recall Bard see related information
Date Initiated by Firm October 06, 2014
Date Posted December 29, 2014
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0876-2015
Recall Event ID 69879
510(K)Number K042449  
Product Classification Syringe, balloon inflation - Product Code MAV
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

Code Information All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407
Recalling Firm/
Ivry Le Temple France
Manufacturer 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
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 24821 units
Distribution US Nationwide Distribution in the states of AZ and CO.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = SEDAT S.A.