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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

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  Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. see related information
Date Initiated by Firm December 14, 2011
Date Posting Updated January 18, 2012
Recall Status1 Terminated 3 on May 22, 2014
Recall Number Z-0807-2012
Recall Event ID 60720
510(K)Number K842375  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

Rx Only, Sterile EO, Nonpyrogenic. Model number #'s :
67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531.

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 2009081553 2009100568, 2009081554 2009101120, 2009081555 2009101121, 2009081948 200910C009, 2009081949 200910C053, 2009081950 200910C152, 200908C070 2009110285, 200908C142 2009110286, 2009090208 2009110287, 2009090209 2009110288, 2009090210 2009110289, 2009090690 2009110290, 2009090691 2009110291, 2009091622 2009110292, 200909C001 200911R240, 200909C089 2009120938, 2009100225 2009120939, 2009100226 2009121508, 2009100564 2009121509, 2009100565 200912C044, 2009101112 200912C083, 2009101113 2010010310, 2009101114 2010010311, 200910C006 2010010312, 2009110280 2010010366, 2009110281 2010012930, 2009110282 201001C010, 2009110283 201001C064, 2009110284 201001C127, 200911C140 2010020302, 2009120230 2010020303, 2009120933 2010020304, 2009120934 2010020305, 2009120935 2010020306, 2009120936 2010022286, 2009120937 2010022287, 2009121506 2010022288, 2009121507 2010022289, 2009121720 2010022290, 2009121721 2010022291, 2009121722 201002C004, 200912C043 2010030389, 200912C074 2010030390, 200912C154 2010030391, 2010010305 2010030392, 2010010306 2010030393, 2010010307 2010031089, 2010010308 2010031090, 2010010309 2010031091, 2010010364 2010031092, 2010010365 2010032293, 2010011397 2010032294, 2010011398 2010032295, 2010011399 2010032964, 2010012929 2010032965, 201001C020 2010032966, 201001C062 201003C117, 201001C117 201003C164, 2010020298 2010040068, 2010020299 2010040069, 2010020300 2010040371, 2010020301 2010040372, 2010021532 2010040373, 2010021533 2010041090, 2010021534 2010041091, 2010022281 201004C037, 2010022282 2010050238, 2010022283 2010050244, 2010022284 2010050245, 2010022285 2010050249, 2010030385 2010050416, 2010030386 2010050799, 2010030387 2010050808, 2010030388 2010050986, 2010031082 2010060125, 2010031083 2010060126, 2010031084 2010060800, 2010031085 2010060801, 2010031086 2010060915, 2010031087 2010060916, 2010031088 2010061606, 2010032289 2010061608, 2010032290 2010062012, 2010032291 2010062013, 2010032292 2010062164, 2010032961 2010062166, 2010032962 2010062637, 2010032963 2010062638, 201003C063 201006C076, 201003C064 2010070020, 201004C059 2010070598, 2010050497 2010070600, 2010050690 2010070861, 2010050798 2010070863, 2010051059 2010071015, 2010051061 2010071016, 2010051063 2010071415, 2010051065 2010071424, 2010060127 2010071502, 2010060128 2010072019, 2010060250 201007C035, 2010060251 2010080359, 2010060920 2010080360, 2010061255 2010080393, 2010061257 2010080639, 2010061260 2010080641, 2010061830 2010080677, 2010061831 2010080683, 2010061832 2010081225, 2010062168 2010081334, 2010062169 2010081504, 2010062170 2010081599, 2010062634 2010081825, 2010062636 201008C051, 201006C077 2010090437, 2010070019 2010090773, 2010070352 2010090933, 2010070354 2010091677, 2010070398 2010092141, 2010070736 2010092449, 2010070737 2010092660, 2010070829 201009C033, 2010070831 2010100586, 2010071012 2010100690, 2010071013 2010101145, 2010071857 2010101147, 2010071858 2010101379, 2010072018 2010101614, 201007C040 2010101618, 2010080006 2010102210, 2010080183 2010102394, 2010080185 2010102395, 2010080558 201010C030, 2010080560 2010110029, 2010080697 2010110312, 2010080713 2010110643, 2010080933 2010111145, 2010080973 2010111735, 2010081086 2010111907, 2010081332 201011C090, 2010081597 201011C134, 2010081824 2010120053, 2010082114 2010120134, 201008C050 2010120295, 2010090447 2010121008, 2010090671 2010121428, 2010090928 2010121566, 2010090929 2010121813, 2010090956 2010121933, 2010091811 2010122266, 2010092140 201012C043, 2010092653 201012C081, 201009C035 2011010053, 2010100174 2011010283, 2010100175 2011010499, 2010100381 2011010758, 2010100585 2011011139, 2010100961 2011011312, 2010101324 2011011766, 2010101325 2011020027, 2010101477 2011020057, 2010101480 2011020214, 2010101781 2011020775, 2010101783 2011020957, 2010102214 2011021356, 2010102216 2011021460, 201010C039 2011021519, 2010110034 2011022136, 2010110340 201102C023, 2010110640 201102C101, 2010111149 2011030025, 2010111457 2011030096, 2010111575 2011030175, 2010111733 201103054
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
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 614,382
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 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 = DWF and Original Applicant = DLP, INC.
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