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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Everest Disposable Inflation Device

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  Class 2 Device Recall Medtronic Everest Disposable Inflation Device see related information
Date Initiated by Firm July 16, 2010
Date Posted August 25, 2010
Recall Status1 Terminated 3 on June 07, 2011
Recall Number Z-2272-2010
Recall Event ID 56276
510(K)Number K942269  K960983  
Product Classification Balloon Inflation Syringe - Product Code MAV
Product Medtronic¿ Everest¿ 30 Disposable Inflation Device, AC3200.

Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Code Information Lot numbers: 50517324.
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact Same
978-777-0042
Manufacturer Reason
for Recall		 Product sterility may be compromised due to breach of package seal integrity.
FDA Determined
Cause 2		 Packaging process control
Action Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.
Quantity in Commerce 768 units
Distribution Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
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 = MEDTRONICS INTERVENTIONAL VASCULAR
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