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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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 Class 2 Device Recall Medtronicsee related information
Date Initiated by FirmApril 05, 2006
Date PostedJune 01, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-1026-06
Recall Event ID 35236
510(K)NumberK010579 
Product Classification Catheter, Percutaneous - Product Code DQY
Product6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40
Code Information Lot Numbers: 0000002433 0000006514 0000012046 0000027687 0000028673 0000033680 0000033718 0000043780 0000046956 0000067140 0000072965 0000076643 0000080168 0000081106 0000085973 0000095150 0000106493 0000134505 0000172339 178512 182950 186089 202512 205561 208500 211542 214599 215763 221279 222892 
Recalling Firm/
Manufacturer
Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information ContactFred Boucher
978-739-3116
Manufacturer Reason
for Recall
Potential for non-sterility due to loss of package integrity
FDA Determined
Cause 2
Other
ActionMedtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Quantity in Commerce645 units
DistributionNationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQY
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