Class 2 Device Recall Affinity Fusion Oxygenator

• Date Initiated by Firm: December 12, 2022
• Date Posted: January 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1028-2023
• Recall Event ID: 91343
• 510(K)Number: K203111
• Product Classification: Oxygenator, cardiopulmonary bypass - Product Code DTZ
• Product: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
• Code Information: Oxygenator Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169505322, HY2Q32R9 (223366543, 224282023); 00643169572263, HY8L55R5 (222887140, 223145744, 223145745, 223283258, 223323300, 223685612, 223685613, 223685614, 223860888, 223860889, 224043160, 224327270, 224327271, 224454137, 224623800, 224623801, 224659584, 224838251, 224838252, 224838253, 225126458); 00643169618312, HY7S51R10 (223235000, 224155208, 224454025, 224794488, 224861211); 00643169661295, HY8M65R2 (224539804); 00643169713406, HY7V67R9 (223247291, 224112023, 224752769); 00643169724310, HY8S40R2 (222974852, 223196617, 223196618, 223810224, 223810366, 224282014, 224497799, 224497800, 225047871, 225047872); 00643169771260, M530636A (223439641, 223775523, 224138283, 224695541, 225162264, 225415719); 00643169792180, M274404N (223260993, 224168527, 224567881, 224865204, 225161917); 00643169930162, HY8B05R7 (222774169, 222974885, 222974886, 223283250, 223454229, 223896471, 224112064, 224282015, 224453949, 224507422, 224659585); 00643169946392, M274204G (223311070, 223862857, 224271887, 224695322); 00643169949768, M444426D (223531132); 00643169976412, HY9M73R2 (224582508, 225251344); 00763000021252, HY6Y97R26 (223014740, 223196543, 223983908, 224154924, 224516514); 00763000050559, HY7M47R8 (223112615, 223366522, 223644448, 224454009, 224838346, 225270461); 00763000060763, M721606K (223563325, 224492621, 224652866); 00763000075866, HY9Q96R3 (222860770, 222860771, 222875738, 223066095, 223066096); 00763000077747, HY0W84R31 (223112616, 223429352, 223896872, 224414953); 00763000112042, M334821N (223352889, 223547366, 223695436, 223882113, 224164652, 224297753, 224525718, 224651356, 224780948, 225090360, 225208460, 225483418); 00763000140991, M611935D (223240763, 224008698, 224252245, 224695667, 225426642); 00763000142995, HY6Y84R14 (223014738, 223206899, 223206900, 223300938, 223323295, 223603536, 223603537, 223603538, 224327235, 224327236, 224454012, 224546574, 224685133, 224699987, 224726997, 224726999, 224727382, 224743168, 225219595, 225219596); 00763000174651, P392801C (223237110, 223392516, 223712994, 223815497, 223926243, 224033581, 224610493, 225253986); 00763000175726, HY10G12R7 (222941535, 223014639, 223258277, 223558544); 00763000187880, CB8S66R2 (222930122); 00763000197445, HY8E24R13 (222860779, 222860780, 223398133); 00763000211271, HY9R12R13 (223323289, 223685616, 224454131, 224752772, 225126466); 00763000214531, M331107A (223238102, 223482252, 223588905, 223753456, 223926779, 224168541, 224493231, 225235965); 0076300022897, M610804T (223245756, 223521603, 223815838, 223994895, 224252243, 224399667, 225120383); 00763000231491, M330808D (223393285, 223882111, 224139628, 224695324, 225303460); 00763000233259, HY5V41R21 (223112538, 223558455, 224019322, 224327283, 224664752); 00763000236588, HY7E57R17 (224019347, 224582628); 00763000236724, M720805J (224048907, 224865314); 00763000240943, HY2W45R20 (223219504); 00763000242527, HY7X65R18 (223014730, 223235005, 223685624, 223685625, 224155074, 224414984, 224794465, 225311196); 00763000245351, M495523C (223521600, 223735985, 224337085); 00763000265182, CB8J86R3 (223558410, 223895502, 224019274, 224066066, 224327165, 224539656, 224752667, 225353748); 00763000265205, CB10N15R (223558430, 223728393, 223860913, 223931078, 224019167, 224277356, 224565011); 00763000273415, HY8B75R23 (223282991, 223851410, 224454062, 224794462); 00763000275136, HY10P43R5 (223014590, 223173677, 223323145, 223454101, 224794489, 224985037); 00763000278281, M332519B (223238096, 223614706, 223909707, 224188634, 224381032, 225265095, 225561516); 00763000287948, HY9G02R4 (222774121, 223112640, 223558543, 224277436); 00763000288266, HY7W91R22 (223066105, 223323279, 223323280, 223830710, 224196553, 224370537, 224370538, 224664768); 00763000298883, CB10V63R3 (222823221, 223896439, 224112044, 224664697, 224983396); 00763000299835, HY2V10R33 (224066117, 224154914, 224327338, 224838246, 225337312); 00763000306489, HY8H57R16 (223014683, 223409297, 223853111, 224539878); 00763000316976, HY7V82R20 (222941536, 223014659, 223014660, 223283017, 223283018, 223283019, 224155220, 224243237, 224282022, 224454021, 224454022, 224659582, 224923381, 224923382, 225804403); 00763000334697, M540010F (224069885, 225024502); 00763000343347, HY11D58R1 (224794254); 00763000350642, HY10V22R6 (222917032 224154925); 00763000352288, M490123D (223862628, 224047760); 00763000353018, HY8M50R5 (223282999); 00763000356750, HY8B38R15 (222899621, 223409270, 223983893, 224794487); 00763000361426, P390012A (224123003, 224865307, 225651628); 00763000367671, HY10R64R10 (223112646, 223283254, 223603721, 223728593, 223728594, 223942689, 223942690, 224539872, 224923383); 00763000377663, HY11B96R2 (222869948, 223234995, 223764169, 223983907); 00763000378592, HY11G63R (222798773, 223014736, 223628127, 224664756, 224970824); 00763000385934, HY11H58R (222860768, 222860769, 222941490, 224897808); 00763000402495, M344705C (223268203, 223438637, 223789660, 223926249, 224271890, 225426344); 00763000404123, M431404F (223714095, 224033621, 225426912); 00763000412142, M443218G (223521614, 223926950, 224652774, 224948431, 225314012); 00763000414481, M470992C (223124424, 223310002, 223482426, 223569842, 223882106, 224297745, 224567875, 224721052, 224948433, 225208398); 00763000415495, M470265B (223261402, 223712997, 223862860, 224096970); 00763000415587, M470727H (223326985, 223837959); 00763000416645, P491704C (223665087); 00763000417659, M721808E (223311072, 223439643, 223589852, 223862854, 224252232, 224992822, 225389383); 00763000417666, M720413J (223532939, 223672422, 224297750, 224493226, 225415717, 225550859); 00763000418748, M333816C (223422902, 223695949, 223862858, 225236226, 225409827); 00763000423988, M412008A (223294764, 223378885, 223508369, 223672421, 223815829, 223994891, 224188640, 224354075, 224736966, 225161986, 225561607); 00763000424022, M496513C (223236548, 223909333); 00763000431884, M273205L (224312690, 225436686); 00763000431914, M273805F (223182875, 223352898, 223882112, 224096701, 224695311, 224865235, 225236228); 00763000432966, M310871J (223182870, 223312443); 00763000436520, M380925B (223665120); 00763000436605, M335816G (223295048, 223630919, 224077485, 224736698, 225120478); 00763000442972, HY9E87R9 (222941533, 223366512); 00763000447311, HY2S09R18 (223112596, 224154894); 00763000465834, HY10P31R19 (223065701); 00763000473884, HY6W12R19 (223234991, 223566389, 224066152, 224664755, 225311203); 00763000482039, M450473J (223167128, 223378870, 223630914, 223815843, 224008696); 00763000497842, M392419F (224168540, 224652777, 224865195, 225227363, 225409828); 00763000500955, HY11M41R1 (223282965, 224277409, 224879055); 00763000501068, HY3P08R39 (223165009, 223896457); 00763000504243, HY8E13R15 (223154600, 223851352, 224277442, 224539699); 00763000505417, HY2J36R23 (222934515, 223196717, 223498046, 223804411, 224277420, 224453965, 225219083); 00763000507404, HY9S56R16 (223066094, 223498056, 223851378, 224539869, 224923366); 00763000513047, M020506D (223246260, 223278252, 223523171, 224012635); 00763000516178, M460331G (223352894, 223569833, 223862634, 224007265, 224206452, 224610684); 00763000517854, HY9G55R5 (223569027, 223939293, 224112103, 224281970, 224414952, 224582607, 224996023); 00763000520144, HY8N22R9 (222941531, 223409269, 223939249, 224441830, 225059170); 00763000534387, HY8R65R26 (223060741, 223453845, 223645654); 00763000534561, HY6V44R36 (222860767, 223558506, 223804387, 224414937, 225045277, 225353749); 00763000535001, HY9L07R6 (223014777, 223764195, 224019358, 224327282, 224454023); 00763000535018, HY9L80R6 (223196719, 224155183); 00763000535841, HY1W12R36 (223366503, 223983898, 224370590, 225398679); 00763000538798, M444429D (223665123, 224892006); 00763000538828, M721010K (223246969, 223352905, 223507403, 223862849, 224354084); 00763000538989, M336915D (222653269, 223422024, 223569841, 224138269, 224225694, 224907238, 225345201, 225510008, 225651509); 00763000541392, M336912J (223253565, 223422901, 223776487, 224096968, 224224163, 225209650, 225389378, 225651045); 00763000542177, HY9R82R2 (223060800, 225188075); 00763000544454, HY9C49R19 (223283252, 224497859); 00763000548698, HY11N74R7 (222940914); 00763000554224, HY10H68R2 (223323276, 224497861); 00763000557188, HY4953R29 (223366546, 224281948); 00763000559663, M020517G (224033614); 00763000560348, M393040B (223439688, 223952680, 224568271, 225379258); 00763000573218, HY8X39R11 (222941588, 223234999, 223566387, 223828745, 223830706, 224019270, 224019271, 224019272, 224282105, 224414957, 224414958, 224752766, 224784929, 225008578, 225008579); 00763000574352, HY11P20R4 (222918301, 223251170, 223558439, 223983895, 224752768); 00763000574444, M611111K (223238101, 223656856, 223995006, 224441196); 00763000576752, HY11R94R1 (222849317, 222941586, 223804377, 223804378, 224282087, 224752795); 00763000578329, HY11R00R6 (222941584, 223014664, 223323292, 223323293, 223915415, 223915423, 223915425, 224327233, 224327234, 224539757, 224539758, 224963588, 225398672, 225398673); 00763000578466, HY8N78R5 (223451343, 224281999); 00763000578473, HY11M38R8 (223258276, 223498042, 224112091, 224611994); 00763000580636, HY9M86R11 (223165006, 223454161, 223942355, 224079541, 224454554, 224623802, 224838242, 225360931); 00763000580681, HY9D36R7 (223366518, 224539905); 00763000584917, M470854L (223315738, 223378935, 223569830, 223815835, 224008690, 224188632, 224525719); 00763000585655, M460236F (223315735, 223422013, 223467229, 223614713, 223881859, 224122986, 224312684); 00763000586645, M494516D (223245765, 223521606, 223776488, 224008692, 224694764, 225161912, 225346294); 00763000589769, HY11N74R10 (222982291, 223488931, 224112036); 00763000596620, P490607K (223253450, 224122988); 00763000597726, HY8J24R2 (223093362, 223409315, 224539895, 224752695); 00763000597818, M310892A (223363066, 223801585, 223952675, 224493290, 225120375, 225331164); 00763000597825, M310893A (223238090, 223521599, 224206464); 00763000600174, HY11P17R5 (223123286, 223196553, 223833439, 224277435, 224582543); 00763000602772, HY9M47R18 (223129488, 223129493); 00763000603038, M410915A (223328743, 223808306, 225463281); 00763000604301, P390707L (223439635, 223789661, 223969952, 224312696, 224694761, 225161919); 00763000606237, M460336D (223253663, 223752203, 224353778); 00763000608897, SSHY11T03R1 (223409230); 00763000611118, M496610D (223422892, 224096976, 225120482); 00763000612917, M494404C (223268763); 00763000615284, HY9M47R19 (223366472, 223366473, 223366474, 223454148, 223454149, 223454150, 224019275, 224019276, 224019277, 224053398, 224053399, 224155177, 224659580, 224699951, 224854722); 00763000616700, SSHY11U23R (223851120); 00763000618780, HY10M03R5 (223341587, 223558413, 223558414); 00763000629083, M335312B (223525625); 00763000632847, HY11V34R (223494811, 223494812, 223494813, 224453921, 224453922, 224453923, 224514485, 224516187, 224766584); 00763000636753, M333823A (223544690, 223776827); 00763000637514, HY9R33R10 (223601665, 223785673); 00763000639822, M380824C (223689373); 00763000640477, M020519A (223808288, 223815950, 223815951, 224986661, 225181585); 00763000642198, CB11V06R (223764089); 00763000643591, M491724F (224123041, 224440777, 225303506); 00763000646561, HY10P39R4 (223843622); 00763000646974, HY11W65R (224066083, 224111946, 224281897); 00763000648350, HY9E87R10 (223884685, 224497811); 00763000648374, HY11T03R2 (225317558); 00763000648909, M450473K (224297747, 224652781, 224992824, 225161913, 225346289, 225678306); 00763000648930, HY11U21R3 (223940611, 224453940, 224582538); 00763000650605, M310637D (224122625, 225415721); 00763000658632, M490123E (224252234); 00763000668211, P490607L (224289243); 00763000686307, HY11N74R11 (224277404); 00763000688158, HY2S09R20 (224623806); 00763000688844, HY11B96R3 (224301781, 225008561); 00763000690182, M337112T (225415723); 00763000700508, SSHY8M39R6 (224414826, 224453869); 00763000702021, M470734A (224465734, 225254270, 225484632); 00763000702038, M460236G (224610682, 225303511, 225484637, 225683964); 00763000704841, HY11W65R1 (224430010, 224539885, 225270470); 00763000708450, M470265C (224610324, 224694804, 224865188, 225345204, 225528223); 00763000712631, M999465A (224620478); 00763000712686, M335312D (224865285, 225389399); 00763000712716, HY10P39R5 (224681553, 225170550); 00763000715366, M470879A (224652873, 225389371); 00763000718923, M460331H (225090686, 225426909, 225651516); 00763000721381, HY11N74R12 (224714339); 00763000723521, M999464B (224735958, 225463398); 00763000723651, HY11U59R4 (224794256); 00763000733100, M312204E (224988086); 00763000733490, HY8B05R10 (224923351, 225086644, 225086645); 00763000733506, HY7X82R12 (224923357, 224923358); 00763000740184, M490123F (225219958); 00763000740245, HY8E13R17 (225008507, 225353751); 00763000740948, HY11M38R12 (225059160); 00763000743079, M311707F (225173692); 00763000744922, P491620A (225331247); 00763000746797, HY8B75R30 (225408619); 00763000762339, HY11V34R1 (225699280, 225699281); 00763000763121, M470879B (225667573); 00763000764753, M470992D (225615056, 225728238); 20763000300085, M495227J (223261403, 223508312, 224381029, 225474132); 20763000417677, M497549P (223294754, 223422988, 223508366, 223713001, 224122614, 224652867, 225254288, 225484791); 20763000544571, M493718D (223238293, 223378938, 223714097, 224008807, 224337421, 225120475); 20763000661117, M494407A (224170341, 225447056)
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: Medtronic Customer Service; 800-854-3570
• Manufacturer Reason for Recall: An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
• FDA Determined Cause: Process change control
• Action: Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection during the clinical procedure. Consignees were also advised to complete and return the Customer Confirmation Form, and notify personnel or facilities were affected units are located. On about 02/10/2023, Medtronic initiated an expansion and notified customers. Instructions in the customer letter remained the same.
• Quantity in Commerce: 40,498 units
• Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DTZ and Original Applicant = Medtronic