{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106305", "product_res_number": "Z-0813-2012", "event_date_initiated": "2011-12-14", "event_date_posted": "2012-01-18", "recall_status": "Terminated", "event_date_terminated": "2014-05-22", "res_event_number": "60720", "product_code": "DTZ", "k_numbers": [ "K891687" ], "product_description": "Custom Packs/Mexico, \n\nMedtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model #\nDLP6N48R3 & DLP6N48R4. \n\nMedtronic Intersept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1.\n\nThese 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_info": "Model # / Lot #\t\t \t\t DLP6N48R3 DLP6N48R4 TL4F71R1 11241044\t 11465359 11799944 \t\t 11755661 \t\t11713167  11713167 \t\t11669547 \t\t11616953 \t\t11568176 \t\t11509030 \t\t11478537 \t\t11432935 \t\t11414606 \t\t11282018 \t\t11252748 \t\t11239976 \t\t11209356 \t\t11130765 \t\t11110871 \t\t11101609 \t\t11051824 \t\t11015290 \t\t10916961 \t\t10860025 \t\t10816466 \t\t10693674 \t\t10656545 \t\t10588143 \t\t10502496 \t\t10454472 \t\t10426945 \t\t10310272 \t\t10255607  \t\t11669547 \t\t11616953 \t\t11568176 \t\t11509030 \t\t11478537 \t\t11432935 \t\t11414606 \t\t11282018 \t\t11252748 \t\t11239976 \t\t11209356 \t\t11130765 \t\t11110871 \t\t11101609 \t\t11051824 \t\t11015290 \t\t10916961 \t\t10860025 \t\t10816466 \t\t10693674 \t\t10656545 \t\t10588143 \t\t10502496 \t\t10454472 \t\t10426945 \t\t10310272 \t\t10255607", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St. N.E.", "city": "Saint Paul", "state": "MN", "postal_code": "55112", "additional_info_contact": "763-526-6000", "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. \n\nMedtronic has received two reports of patient deaths due to p", "root_cause_description": "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.", "product_quantity": "106", "distribution_pattern": "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.", "openfda": { "k_number": [ "K831122", "K242503", "K990103", "K861641", "K894970", "K223161", "K910107", "K241352", "K912655", "K790356", "K022115", "K140177", "K961530", "K863249", "K872133", "K802328", "K810470", "K811004", "K843955", "K772237", "K102464", "K974085", "K862918", "K191444", "K802719", "K202510", "K103191", "K925626", "K823125", "K802720", "K231414", "K901253", "K050447", "K061628", "K891230", "K932252", "K843956", "K133261", "K810532", "K200683", "K212341", "K964043", "K893704", "K183490", "K872107", "K897068", "K923272", "K833518", "K090450", "K844901", "K882892", "K071494", "K873923", "K772284", "K823273", "K821216", 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