{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Saint Paul", "state": "MN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "70846", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St NE", "address_2": "N/A", "postal_code": "55112-4391", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution: US (nationwide) including all states in continental USA, except DE and including DC and PR; and countries: AUSTRIA, AUSTRALIA, NEW ZEALAND, BELGIUM, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, IRELAND, ITALY, NETHERLANDS, POLAND, PORTUGAL, ROMANIA, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SALVADOR, PANAMA, and CANADA.", "recall_number": "Z-1365-2015", "product_description": "Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.", "product_quantity": "8,269 ( 6,786 US, 1,483 OUS)", "reason_for_recall": "Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.", "recall_initiation_date": "20150323", "center_classification_date": "20150401", "termination_date": "20160811", "report_date": "20150408", "code_info": "Model Lot Number\" BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796 BVT608030 551873 BVT608030 551893 BVT608030 551923 BVT608030 552011 BVT608030 552097 BVT612010 551789 BVT612010 551837 BVT612010 551894 BVT612010 551974 BVT612010 551976 BVT612010 552030 BVT612010 552226 BVT612030 551808 BVT612030 551903 BVT612030 551904 BVT612030 551924 BVT612030 551980 BVT612030 552007 BVT612030 552017 BVT612030 552034 BVT612030 552071 BVT612030 552081 BVT612030 552229 BVT808015 551466 BVT808015 551797 BVT808015 551804 BVT808015 551895 BVT808015 551942 BVT808015 551950 BVT808015 551984 BVT808015 552020 BVT808015 552027 BVT808015 552067 BVT808015 552113 BVT808030 551436 BVT808030 551437 BVT808030 551464 BVT808030 551798 BVT808030 551803 BVT808030 551812 BVT808030 551841 BVT808030 551863 BVT808030 551897 BVT808030 551899 BVT808030 551922 BVT808030 551943 BVT808030 551947 BVT808030 551977 BVT808030 551981 BVT808030 551986 BVT808030 551999 BVT808030 552010 BVT808030 552012 BVT808030 552028 BVT808030 552084 BVT808030 552100 BVT808030 552119 BVT808030 552120 BVT808030 552146 BVT808030 552168 BVT808030 552174 BVT808030 552180 BVT812015 551471 BVT812015 551805 BVT812015 551816 BVT812015 551891 BVT812015 551944 BVT812015 551978 BVT812015 552021 BVT812015 552099 BVT812015 552181 BVT812030 551465 BVT812030 551472 BVT812030 551474 BVT812030 551802 BVT812030 551815 BVT812030 551844 BVT812030 551864 BVT812030 551890 BVT812030 551905 BVT812030 551948 BVT812030 551970 BVT812030 551982 BVT812030 551993 BVT812030 552018 BVT812030 552035 BVT812030 552073 BVT812030 552117 BVT812030 552145 BVT812030 552149 BVT812030 552169 EUT808015 551889 EUT808015 551949 EUT808015 552023 EUT808015 552085 EUT808015 552144 EUT808030 551826 EUT808030 551865 EUT808030 552008 EUT808030 552013 EUT808030 552069 EUT808030 552096 EUT808030 552123 EUT808030 552147 EUT812015 551898 EUT812015 552001 EUT812015 552177 EUT812030 551829 EUT812030 551866 EUT812030 551994 EUT812030 552019 EUT812030 552086 EUT812030 552124 EUT812030 552150 BVT608010 9853174 BVT608010 9864497 BVT608010 9890772 BVT608010 9890931 BVT608010 9925676 BVT608010 9932672 BVT608010 9937308 BVT608010 9937315 BVT608010 9940474 BVT608010 9940614 BVT608010 9976340 BVT608010 9978233 BVT608010 A001589 BVT608010 A001740 BVT608010 A002980 BVT608010 A009064 BVT608010 A009166 BVT608010 A016008 BVT608010 A035757 BVT608010 A038252 BVT608030 9853331 BVT608030 9887597 BVT608030 9887695 BVT608030 9887757 BVT608030 9932042 BVT608030 9932682 BVT608030 9941271 BVT608030 9977037 BVT608030 A001672 BVT608030 A007829 BVT608030 A008148 BVT608030 A008558 BVT608030 A008850 BVT608030 A009028 BVT612010 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CVT808025 A044763 CVT812015 9893271 CVT812015 9894486 CVT812015 9894507 CVT812015 9896406 CVT812015 9900062 CVT812015 9900199 CVT812015 9900233 CVT812015 9900851 CVT812015 9900878 CVT812015 9901624 CVT812015 9901696 CVT812015 9902336 CVT812015 9902390 CVT812015 9902799 CVT812015 9903356 CVT812015 9903996 CVT812015 9904333 CVT812015 9904401 CVT812015 9904600 CVT812015 9904676 CVT812015 9906780 CVT812015 9906817 CVT812015 9906819 CVT812015 9906973 CVT812015 9906983 CVT812015 9906984 CVT812015 9906985 CVT812015 9906986 CVT812015 9906987 CVT812015 9909485 CVT812015 9910328 CVT812015 9910934 CVT812015 9912034 CVT812015 9912387 CVT812015 9932594 CVT812015 9933474 CVT812015 9933813 CVT812015 9933924 CVT812015 9934192 CVT812015 9934730 CVT812015 9936820 CVT812015 9937095 CVT812015 9937806 CVT812015 9942701 CVT812015 9943235 CVT812015 9945140 CVT812015 9947355 CVT812015 9948025 CVT812015 9949589 CVT812015 9950220 CVT812015 9950943 CVT812015 9951445 CVT812015 9953905 CVT812015 9964154 CVT812015 9964382 CVT812015 9965001 CVT812015 9965223 CVT812015 9966305 CVT812015 9970643 CVT812015 9975919 CVT812015 9976027 CVT812015 9976092 CVT812015 9976195 CVT812015 9980432 CVT812015 9980496 CVT812015 9980603 CVT812015 9980686 CVT812015 A001103 CVT812015 A001122 CVT812015 A001266 CVT812015 A001418 CVT812015 A005416 CVT812015 A006294 CVT812015 A006366 CVT812015 A006531 CVT812015 A006968 CVT812015 A007525 CVT812015 A008412 CVT812015 A009355 CVT812015 A009448 CVT812015 A010194 CVT812015 A010509 CVT812015 A010512 CVT812015 A010595 CVT812015 A010807 CVT812015 A011251 CVT812015 A011386 CVT812015 A011547 CVT812015 A011655 CVT812015 A011968 CVT812015 A012231 CVT812015 A012385 CVT812015 A012657 CVT812015 A012708 CVT812015 A012807 CVT812015 A012901 CVT812015 A015455 CVT812015 A015576 CVT812015 A015630 CVT812015 A015679 CVT812015 A017341 CVT812015 A029499 CVT812015 A029718 CVT812015 A030068 CVT812015 A030174 CVT812015 A030286 CVT812015 A030844 CVT812015 A030896 CVT812015 A033763 CVT812025 9893274 CVT812025 9895136 CVT812025 9896391 CVT812025 9897646 CVT812025 9898548 CVT812025 9902472 CVT812025 9903613 CVT812025 9903781 CVT812025 9904683 CVT812025 9906814 CVT812025 9906967 CVT812025 9906969 CVT812025 9906988 CVT812025 9907077 CVT812025 9907528 CVT812025 9910342 CVT812025 9910439 CVT812025 9910590 CVT812025 9910598 CVT812025 9911111 CVT812025 9911416 CVT812025 9911492 CVT812025 9911683 CVT812025 9911812 CVT812025 9912503 CVT812025 9925351 CVT812025 9933666 CVT812025 9934311 CVT812025 9934575 CVT812025 9934700 CVT812025 9935143 CVT812025 9935199 CVT812025 9935494 CVT812025 9935636 CVT812025 9935900 CVT812025 9936109 CVT812025 9936173 CVT812025 9936570 CVT812025 9936597 CVT812025 9936848 CVT812025 9937896 CVT812025 9937968 CVT812025 9938060 CVT812025 9938219 CVT812025 9938831 CVT812025 9938896 CVT812025 9941711 CVT812025 9945304 CVT812025 9947559 CVT812025 9948088 CVT812025 9949321 CVT812025 9949934 CVT812025 9950324 CVT812025 9951247 CVT812025 9951521 CVT812025 9952927 CVT812025 9957277 CVT812025 9957530 CVT812025 9959854 CVT812025 9959944 CVT812025 9960241 CVT812025 9960324 CVT812025 9960635 CVT812025 9960807 CVT812025 9961583 CVT812025 9961682 CVT812025 9962504 CVT812025 9963558 CVT812025 9964120 CVT812025 9964347 CVT812025 9964448 CVT812025 9965066 CVT812025 9965335 CVT812025 9966329 CVT812025 9966429 CVT812025 9966999 CVT812025 9967656 CVT812025 9967694 CVT812025 9968180 CVT812025 9969396 CVT812025 9972428 CVT812025 9972429 CVT812025 9972819 CVT812025 9972867 CVT812025 9972966 CVT812025 9973025 CVT812025 9973678 CVT812025 9973766 CVT812025 9973839 CVT812025 9974903 CVT812025 9978572 CVT812025 A002552 CVT812025 a002576 CVT812025 A003508 CVT812025 A004824 CVT812025 A013919 CVT812025 A014083 CVT812025 A017367 CVT812025 A018961 CVT812025 A027444 CVT812025 A027983 CVT812025 A028254 CVT812025 A028619 CVT812025 A029629 CVT812025 A031054 CVT812025 A031147 CVT812025 A031550 CVT812025 A033145 CVT812025 A033393 CVT812025 A034276 CVT812025 A034293 CVT812025 A034306 CVT812025 A034394 CVT812025 A034472 CVT812025 A034489 CVT812025 A034493 CVT812025 A034757 CVT812025 A034939 CVT812025 A035121 CVT812025 A035160 CVT812025 A035202 CVT812025 A035249 CVT812025 A035798 CVT812025 A035827 CVT812025 A035841 CVT812025 A035904 CVT812025 A035981 CVT812025 A039047 CVT812025 A039156 CVT812025 A039193 CVT812025 A039261 CVT812025 A039514 CVT812025 A044458 EVT808015 9912933 EVT808015 9913003 EVT808015 9913878 EVT808015 9928819 EVT808015 9929499 EVT808015 9929826 EVT808015 9929913 EVT808015 9929937 EVT808015 9929971 EVT808015 9929980 EVT808015 9930297 EVT808015 9930464 EVT808015 9930797 EVT808015 9930951 EVT808015 9931141 EVT808015 9931509 EVT808015 9931544 EVT808015 9954672 EVT808015 9955126 EVT808015 9955275 EVT808015 9956347 EVT808015 9956434 EVT808015 9957156 EVT808015 9957828 EVT808015 9966854 EVT808015 9970652 EVT808015 9978824 EVT808015 9979159 EVT808015 A000335 EVT808015 A037167 EVT808015 A037256 EVT808015 A037564 EVT808015 A037655 EVT808015 A037889 EVT808015 A038527 EVT808015 A038615 EVT808025 9912629 EVT808025 9913219 EVT808025 9913619 EVT808025 9913647 EVT808025 9913792 EVT808025 9928202 EVT808025 9928286 EVT808025 9928957 EVT808025 9929625 EVT808025 9929921 EVT808025 9929942 EVT808025 9929975 EVT808025 9929984 EVT808025 9930119 EVT808025 9954578 EVT808025 9954720 EVT808025 9955164 EVT808025 9955302 EVT808025 9956600 EVT808025 9957360 EVT808025 9962625 EVT808025 9966593 EVT808025 9966889 EVT808025 9967158 EVT808025 9968025 EVT808025 9970097 EVT808025 A000083 EVT808025 A003835 EVT808025 A033810 EVT808025 A033896 EVT808025 A033961 EVT808025 A034350 EVT808025 A034450 EVT808025 A034684 EVT808025 A034868 EVT808025 A035008 EVT812015 9928226 EVT812015 9928916 EVT812015 9929597 EVT812015 9930754 EVT812015 9931680 EVT812015 9954559 EVT812015 9954683 EVT812015 9955186 EVT812015 9956478 EVT812015 9956505 EVT812015 9956660 EVT812015 9961108 EVT812015 9966390 EVT812015 9966680 EVT812015 9966940 EVT812015 9967242 EVT812015 9968054 EVT812015 9968734 EVT812015 9969632 EVT812015 A036237 EVT812015 A037768 EVT812015 A037831 EVT812015 A038430 EVT812015 A043048 EVT812025 9928255 EVT812025 9929653 EVT812025 9929681 EVT812025 9930088 EVT812025 9930558 EVT812025 9930606 EVT812025 9930619 EVT812025 9930695 EVT812025 9930713 EVT812025 9931941 EVT812025 9953991 EVT812025 9954138 EVT812025 9954398 EVT812025 9954500 EVT812025 9954604 EVT812025 9955002 EVT812025 9955236 EVT812025 9957446 EVT812025 9959050 EVT812025 9959087 EVT812025 9960088 EVT812025 9960218 EVT812025 9961172 EVT812025 9965700 EVT812025 9965782 EVT812025 9967620 EVT812025 9967622 EVT812025 9975240 EVT812025 9975335 EVT812025 9975412 EVT812025 9975547 EVT812025 9976833 EVT812025 9976953 EVT812025 9977238 EVT812025 9979266 EVT812025 A000273 EVT812025 A033893" } ] }