{ "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": "116100", "product_res_number": "Z-0908-2013", "event_date_initiated": "2013-02-19", "event_date_posted": "2013-03-05", "recall_status": "Terminated", "event_date_terminated": "2013-11-21", "res_event_number": "64417", "product_code": "DWF", "k_numbers": [ "K120988", "K842375" ], "product_description": "Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. \n\nModel numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.", "code_info": "Model\tCatalog#\t Lot 67312\t6731210NO\t2012090293 67312\t6731210NO\t2012090294 67312\t6731210NO\t2012090337 67312\t6731210NO\t2012100039 67312\t6731210NO\t2012100086 67312\t6731210NO\t2012100087 67312\t6731210NO\t2012100161 67312\t6731210NO\t2012110326 67312\t6731210NO\t2012110767 67312\t6731210NO\t2012110899 67312\t6731210NO\t2012111721 67314\t6731410NO\t2012090416 67314\t6731410NO\t2012090435 67314\t6731410NO\t2012090571 67314\t6731410NO\t2012090572 67314\t6731410NO\t2012100040 67314\t6731410NO\t2012100041 67314\t6731410NO\t2012100107 67314\t6731410NO\t2012101346 67314\t6731410NO\t2012110007 67314\t6731410NO\t2012110008 67314\t6731410NO\t2012110327 67314\t6731410NO\t2012111419 67314\t6731410NO\t2012111420 67314\t6731410NO\t2012120019 67316\t6731610NO\t2012090239 67316\t6731610NO\t2012090389 67316\t6731610NO\t2012090854 67316\t6731610NO\t2012091024 67316\t6731610NO\t2012110030 67316\t6731610NO\t2012110144 67316\t6731610NO\t2012110394 67316\t6731610NO\t2012110395 67316\t6731610NO\t2012110396 67318\t67318\t2012110850 67318\t67318\t2012110851 67318\t67318\t2012111013 67318\t67318\t2012111789 67318\t67318\t2012120328 67318\t67318\t2012120330 67318\t67318\t2013010932 67318\t67318\t2013010933 67318\t67318\t2013011226 67320\t67320\t2012121379 67320\t67320\t2012121629 67320\t67320\t2013010002 67320\t67320\t2013010105 69312\t6931210NO\t2012090236 69312\t6931210NO\t2012110010 69312\t69312INK\t2012090296 69312\t69312INK\t2012100905 69312\t69312INK\t2012110251 69312\t69312INK\t2012110252 69314\t6931410NO\t2012090855 69314\t6931410NO\t2012091222 69316\t6931610NO\t2012090240 69318\t69318\t2012111225 69318\t69318\t2013010966 69320\t69320\t2012121408 69320\t69320\t2013010003 69322\t69322\t2012111723 69322\t69322\t2012120118 69322\t69322\t2012120513 69322\t69322\t2013010812 69322\t69322\t2013010935 69324\t69324\t2012121060 69324\t69324\t2012121061 69324\t69324\t2012121062 69324\t69324\t2012121148 69324\t69324\t2012121149 69324\t69324\t2012121362 69328\t69328\t2012110184 69328\t69328\t2012120660 69328\t69328\t2012120661 69328\t69328\t2012120992 69328\t69328\t2012121004 69328\t69328\t2012121005 69328\t69328\t2012121006 69328\t69328\t2012121150 69328\t69328\t2012121192 69328\t69328\t2012121193 69328\t69328\t2012121364 69328\t69328\t201301C189 69331\t69331\t2012121063 69331\t69331\t2012121064 69331\t69331\t2012121151 69331\t69331\t2012121382 69331\t69331\t2013010224 69331\t69331\t2013010437 69331\t69331\t2013010438 69331\t69331\t2013010510 69331\t69331\t2013010511 CB67314\tCB67314\t206409412 CB67318\tCB67318\t206513557 CB67318\tCB67318\t206642303", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St NE", "city": "Saint Paul", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "763-526-6000", "reason_for_recall": "Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.", "root_cause_description": "Nonconforming Material/Component", "action": "Consignees were sent a Medtronic \"Urgent Medical Device Recall\" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue.", "product_quantity": "13,691 (6711 USA; 6980 OUS)", "distribution_pattern": "Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.", "openfda": { "k_number": [ "K910021", "K884310", "K862190", "K032632", "K874899", "K895352", "K821316", "K143083", "K873212", "K961270", "K832475", "K092509", "K863740", "K120072", 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Vascular, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4210", "device_class": "2" } } ] }