{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106303", "product_res_number": "Z-0811-2012", "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": "DWF", "k_numbers": [ "K854487" ], "product_description": "Medtronic, DLP, DLP Malleable Single Stage Venous CannulaeRx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. \n Model # 91037.\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 # 91037  2008120758 2008121114 2009020137 2009040853 2009050547 2009061436 2010051435 2010101499 2011011022 2011030416 2011041113", "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": "883", "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": [ "K180979", "K190594", "K122913", "K971023", "K032977", "K874852", "K813037", "K201100", "K241248", "K831332", "K203067", "K910021", "K791832", "K150567", "K143107", "K002857", "K253998", "K123187", "K131666", "K090533", "K905224", "K872043", "K924529", "K854640", "K964200", "K971021", "K865079", "K022174", "K932208", "K896777", "K032041", "K881074", "K961927", "K790246", "K950814", "K801359", "K111147", "K120987", "K171308", "K861496", "K993677", "K872762", "K002273", "K060101", "K791858", "K831130", "K023251", "K141951", "K801770", "K253106", "K133236", "K792202", "K930620", "K031151", "K801398", "K902394", 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