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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 Medtronic see related information
Date Initiated by Firm April 05, 2006
Date Posted June 01, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-1075-06
Recall Event ID 35236
510(K)Number K981198  
Product Classification Catheter, Percutaneous - Product Code DQY
Product 6F ZUMA SR4.0
CATHETER ZM6SR40 ZM 6F 100CM SR4.0 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: ZM6SR40
Code Information Lot Numbers: 0000000770 0000002134 0000028207 0000043814 0000090410 0000103759 0000125699 0000137834 0000151268 0000164481 127482 128283 128616 128988 130040 130595 132042 134208 135297 136396 138223 139414 141461 145170 152777 154356 155657 160606 166965 175986 186044 188373 204387 208088 217819 223496 
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information Contact Fred Boucher
978-739-3116
Manufacturer Reason
for Recall		 Potential for non-sterility due to loss of package integrity
FDA Determined
Cause 2		 Other
Action Medtronic 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 Commerce 577 units
Distribution Nationwide 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 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 = DQY and Original Applicant = MEDTRONICS INTERVENTIONAL VASCULAR
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