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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-0958-06
Recall Event ID 35236
510(K)NumberK021256 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductCATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 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 Number: LA6SR35
Code Information Lot Numbers: 0000001696 0000005659 0000009476 0000042018 0000044719 0000045231 0000064050 0000068017 0000068397 0000082398 0000084406 0000085999 0000095233 0000104293 0000104342 0000115247 0000123723 0000125309 0000138086 0000150459 0000169173 0000176133 176535 186865 201667 204626 205350 211785 213371 214942 220436 
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 Commerce680 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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