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U.S. Department of Health and Human Services

Class 2 Device Recall Beacon Tip Torcon NB Advantage Catheter

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  Class 2 Device Recall Beacon Tip Torcon NB Advantage Catheter see related information
Date Initiated by Firm April 15, 2016
Date Posted August 22, 2016
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-2610-2016
Recall Event ID 74010
510(K)Number K133130  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Beacon Tip Torcon NB Advantage Catheter
Catheter, Intravascular, Diagnostic
Code Information All Lots. Catalog prefixes HNBR5.0 and HNBR6.0  Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480 G12570 HNBR5.0-35-100-P-NS-DAV G08699 HNBR5.0-35-100-P-NS-FC3 G11204 HNBR5.0-35-100-P-NS-H1 G08421 HNBR5.0-35-100-P-NS-H3 G08918 HNBR5.0-35-100-P-NS-HN1 G09741 HNBR5.0-35-100-P-NS-HN4 G08917 HNBR5.0-35-100-P-NS-HNK1 G27811 HNBR5.0-35-100-P-NS-JB1 G08472 HNBR5.0-35-100-P-NS-JB2 G08809 HNBR5.0-35-100-P-NS-JB3 G08577 HNBR5.0-35-100-P-NS-MAN G08511 HNBR5.0-35-100-P-NS-MIK G11652 HNBR5.0-35-100-P-NS-MPA G11468 HNBR5.0-35-100-P-NS-SIM1 G08471 HNBR5.0-35-100-P-NS-SIM2 G08422 HNBR5.0-35-100-P-NS-SIM3 G08597 HNBR5.0-35-100-P-NS-VERT G11483 HNBR5.0-35-100-P-NS-WAIKATO G13803 HNBR5.0-35-100-P-NS-WNBG G08805 HNBR5.0-35-125-P-NS-C2 G12899 HNBR5.0-35-125-P-NS-C-PS G31970 HNBR5.0-35-125-P-NS-DAV G11375 HNBR5.0-35-125-P-NS-H1 G13258 HNBR5.0-35-125-P-NS-SIM2 G11658 HNBR5.0-35-125-P-NS-VANSCHIE1 G35733 HNBR5.0-35-125-P-NS-VANSCHIE2 G35734 HNBR5.0-35-125-P-NS-VANSCHIE3 G35735 HNBR5.0-35-125-P-NS-VANSCHIE4 G35736 HNBR5.0-35-125-P-NS-VANSCHIE5 G35737 HNBR5.0-35-125-P-NS-VS1 G35974 HNBR5.0-35-125-P-NS-WAIKATO G27813 HNBR5.0-35-40-P-NS-KMP G09751 HNBR5.0-35-40-P-NS-TEGT G13804 HNBR5.0-35-40-P-NS-VANSCHIE1 G31410 HNBR5.0-35-40-P-NS-VANSCHIE2 G31409 HNBR5.0-35-40-P-NS-VANSCHIE3 G31408 HNBR5.0-35-60-P-NS-BELL-1.5 G27815 HNBR5.0-35-65-P-NS-C1 G08441 HNBR5.0-35-65-P-NS-C2 G08442 HNBR5.0-35-65-P-NS-C3 G08443 HNBR5.0-35-65-P-NS-DAV G11414 HNBR5.0-35-65-P-NS-KMP G11458 HNBR5.0-35-65-P-NS-LEV1 G11459 HNBR5.0-35-65-P-NS-LEV2 G11460 HNBR5.0-35-65-P-NS-RC1 G08469 HNBR5.0-35-65-P-NS-RC2 G08470 HNBR5.0-35-65-P-NS-RDC G08596 HNBR5.0-35-65-P-NS-RIM G08444 HNBR5.0-35-65-P-NS-RLG G11380 HNBR5.0-35-65-P-NS-SHK0.8 G32368 HNBR5.0-35-65-P-NS-SIM1 G09853 HNBR5.0-35-65-P-NS-SIM2 G11478 HNBR5.0-35-65-P-NS-VANSCHIE1 G13795 HNBR5.0-35-65-P-NS-VANSCHIE2 G13794 HNBR5.0-35-65-P-NS-VANSCHIE3 G13792 HNBR5.0-35-65-P-NS-VANSCHIE4 G13783 HNBR5.0-35-65-P-NS-VANSCHIE5 G13793 HNBR5.0-35-70-P-NS-DAV G27820 HNBR5.0-35-80-P-NS-C1 G10063 HNBR5.0-35-80-P-NS-C2 G11202 HNBR5.0-35-80-P-NS-CHG4 G13711 HNBR5.0-35-80-P-NS-JR3.5 G11453 HNBR5.0-35-80-P-NS-MPA G09888 HNBR5.0-35-80-P-NS-RDC G13703 HNBR5.0-35-80-P-NS-RIM G12595 HNBR5.0-38-100-P-NS-C1 G09344 HNBR5.0-38-100-P-NS-C2 G09967 HNBR5.0-38-100-P-NS-CK1 G08839 HNBR5.0-38-100-P-NS-DAV G08581 HNBR5.0-38-100-P-NS-H1 G08419 HNBR5.0-38-100-P-NS-H3 G11199 HNBR5.0-38-100-P-NS-HN4 G11200 HNBR5.0-38-100-P-NS-HN5 G09899 HNBR5.0-38-100-P-NS-JB1 G08583 HNBR5.0-38-100-P-NS-JB2 G09654 HNBR5.0-38-100-P-NS-JB3 G11192 HNBR5.0-38-100-P-NS-JIM G11446 HNBR5.0-38-100-P-NS-JR4 G10874 HNBR5.0-38-100-P-NS-KMP G11457 HNBR5.0-38-100-P-NS-MAN G11201 HNBR5.0-38-100-P-NS-MPA G11205 HNBR5.0-38-100-P-NS-MPB G11206 HNBR5.0-38-100-P-NS-RDC G11379 HNBR5.0-38-100-P-NS-RIM G12870 HNBR5.0-38-100-P-NS-SHETTY-050181 G11475 HNBR5.0-38-100-P-NS-SIM1 G08584 HNBR5.0-38-100-P-NS-SIM2 G08420 HNBR5.0-38-100-P-NS-SIM3 G08585 HNBR5.0-38-100-P-NS-TEGT G11193 HNBR5.0-38-100-P-NS-VERT G11484 HNBR5.0-38-100-P-NS-VS2 G11487 HNBR5.0-38-100-P-NS-VS3 G11488 HNBR5.0-38-100-P-NS-VTK G27829 HNBR5.0-38-100-P-NS-WNBG G08582 HNBR5.0-38-110-P-NS-VERT G12128 HNBR5.0-38-120-P-NS-DAV G27830 HNBR5.0-38-125-P-NS-H1 G11378 HNBR5.0-38-125-P-NS-HN2 G11523 HNBR5.0-38-125-P-NS-HN5 G13119 HNBR5.0-38-125-P-NS-JB1 G11726 HNBR5.0-38-125-P-NS-JB2 G11883 HNBR5.0-38-125-P-NS-MPA G12154 HNBR5.0-38-125-P-NS-SIM1 G12072 HNBR5.0-38-125-P-NS-SIM2 G11517 HNBR5.0-38-125-P-NS-VERT G12170 HNBR5.0-38-125-P-NS-VTK G11642 HNBR5.0-38-40-P-NS-0 G24825 HNBR5.0-38-40-P-NS-KMP G09548 HNBR5.0-38-65-P-NS-C1 G08446 HNBR5.0-38-65-P-NS-C2 G08447 HNBR5.0-38-65-P-NS-C3 G08448 HNBR5.0-38-65-P-NS-DAV G11435 HNBR5.0-38-65-P-NS-FINCK-101979 G11437 HNBR5.0-38-65-P-NS-H1 G11395 HNBR5.0-38-65-P-NS-JB1 G11208 HNBR5.0-38-65-P-NS-KMP G09469 HNBR5.0-38-65-P-NS-LEV1 G11194 HNBR5.0-38-65-P-NS-LEV2 G11207 HNBR5.0-38-65-P-NS-LEV3 G11461 HNBR5.0-38-65-P-NS-MPA G11195 HNBR5.0-38-65-P-NS-MPB G11470 HNBR5.0-38-65-P-NS-RC1 G08641 HNBR5.0-38-65-P-NS-RC2 G08642 HNBR5.0-38-65-P-NS-RDC G08578 HNBR5.0-38-65-P-NS-RH G10080 HNBR5.0-38-65-P-NS-RIM G10082 HNBR5.0-38-65-P-NS-RLG G09371 HNBR5.0-38-65-P-NS-SHK1.0 G11476 HNBR5.0-38-65-P-NS-SIM1 G08677 HNBR5.0-38-65-P-NS-SIM2 G08625 HNBR5.0-38-65-P-NS-SIM3 G08849 HNBR5.0-38-65-P-NS-TEGT G11377 HNBR5.0-38-65-P-NS-VERT G11485 HNBR5.0-38-65-P-NS-VS1 G11486 HNBR5.0-38-65-P-NS-VS2 G12715 HNBR5.0-38-65-P-NS-VSC1 G20791 HNBR5.0-38-65-P-NS-VSC2 G20038 HNBR5.0-38-65-P-NS-VSC3 G21042 HNBR5.0-38-75-P-NS-CHG2.5 G27848 HNBR5.0-38-75-P-NS-CHG3 G30040 HNBR5.0-38-75-P-NS-CHG-D G27846 HNBR5.0-38-80-P-NS-C1 G11203 HNBR5.0-38-80-P-NS-C2 G08586 HNBR5.0-38-80-P-NS-CHG2.5 G11430 HNBR5.0-38-80-P-NS-CHG3 G13573 HNBR5.0-38-80-P-NS-CHG-A G13559 HNBR5.0-38-80-P-NS-CHG-B G13560 HNBR5.0-38-80-P-NS-CHG-C G13561 HNBR5.0-38-80-P-NS-CHG-D G13562 HNBR5.0-38-80-P-NS-CHG-E G13563 HNBR5.0-38-80-P-NS-JR1 G13370 HNBR5.0-38-80-P-NS-MIK G09312 HNBR5.0-38-80-P-NS-MK1A G11465 HNBR5.0-38-80-P-NS-MPA G11467 HNBR5.0-38-80-P-NS-MPB G11469 HNBR5.0-38-80-P-NS-RC1 G11530 HNBR5.0-38-80-P-NS-RC2 G11471 HNBR5.0-38-80-P-NS-RDC G12293 HNBR5.0-38-80-P-NS-RH G27852 HNBR5.0-38-80-P-NS-RIM G10028 HNBR5.0-38-80-P-NS-RLG G27853 HNBR5.0-38-80-P-NS-SIM2 G11886 HNBR5.0-38-80-P-NS-VS G11209 HNBR5.0-38-80-P-NS-VS1 G11189 HNBR5.0-38-80-P-NS-VS2 G11190 HNBR5.0-38-80-P-NS-VS3 G11191 HNBR6.0-38-40-P-NS-KMP G27856 HNBR6.0-38-65-P-NS-0 G27858 HNBR6.0-38-65-P-NS-KMP G27860 
Recalling Firm/
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
Manufacturer Reason
for Recall
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.
Quantity in Commerce 2,662,505
Distribution Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
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 = DQO and Original Applicant = COOK, INC.