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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae

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 Class 2 Device Recall Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0810-2012
Recall Event ID 60720
510(K)Number K022272 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae.

Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s
68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 68132, 68134, 68136, 68138, 68140.

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Code Information 3 2009121500 2010120012
2010101409 2011060943 2009121718 2010120132
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201010C036 2011071095 2010022270 2011020052
201010C037 2011100259 2010022271 2011020335
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2011060942
2011070538
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201107C057
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201108C132
2011090264
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2011100987
2011102100
2011102791





68132 68134 68136 68138 68140
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2010022275 2011050626
2010022276 2011050630
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2010050495 2011062015
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2010050805 2011070228
2010062668 2011070969
2010072181 2011071094
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2010080408 201108C221
2010080494 2011090018
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2010091092 2011100117
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2010100152 2011101586
2010101139
2010101140
2010110531
2010111141
2010111142
2010120636
2011010557
2011011652
2011020053
2011021161
2011031034
2011031179
2011031824
2011040181
2011040583
2011040693
2011040807
2011041481
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-526-6000
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
FDA Determined
Cause 2
Labeling design
Action Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
Quantity in Commerce 139,777
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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