—#186156

Product

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

FDA product code: DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K131964
Affected lot / code info: 560BC: GTIN 00885074539386, Serial Numbers: 560B100094, 560B100212, 560B100244, 560B100257, 560B100274, 560B100283, 560B100418, 560B100439, 560B100482 560BC1: GTIN 00613994450326, Serial Numbers: 560B100901, 560B101368 560BCS: GTIN 00613994258236, Serial Numbers: 560B100369, 560B100376, 560B100472, 560B100495, 560B100496 560BCS1: GTIN: 00613994450463, Serial Numbers: 560B100191, 560B100690, 560B100783, 560B100806, 560B100820, 560B100871, 560B100896, 560B101062, 560B101187, 560B101318, 560B101344, 560B101470, 560B101499, 560B101504, 560B101519, 560B101593, 560B101526 GTIN 00613994526052, Serial Numbers: 560B102610, 560B102725 GTIN 00643169201033, Serial Numbers: 560B101838 GTIN 00643169201651, Serial Numbers: 560B101834 GTIN 00643169315822, Serial Numbers: 560B100127, 560B101694, 560B101700, 560B101805, 560B101976, 560B101996, 560B102080, 560B102118, 560B102185, 560B102194, 560B102204, 560B102210, 560B102215, 560B102265, 560B102336, 560B102426, 560B102493, 560B102518, 560B102547, 560B102559, 560B102598, 560B102761, 560B102762, 560B102763, 560B102764, 560B102765, 560B102766 GTIN 00763000135447, Serial Numbers: 560B102711, 560B102717, 560B102718, 560B102720, 560B102721, 560B102722, 560B102723, 560B102724, 560B102726, 560B102727, 560B102730, 560B102731, 560B102732, 560B102733, 560B102734, 560B102735, 560B102736, 560B102737, 560B102738, 560B102739, 560B102740, 560B102741, 560B102742, 560B102743, 560B102745, 560B102746, 560B102747, 560B102748, 560B102750, 560B102751, 560B102752, 560B102754, 560B102755, 560B102756, 560B102757, 560B102758, 560B102760, 560B102767, 560B102768, 560B102769, 560B102770, 560B102771, 560B102772, 560B102773, 560B102774, 560B102775, 560B102776 GTIN 00763000159412, Serial Numbers: 560B102930, 560B102931, 560B102932, 560B102933, 560B102934 GTIN 00763000236526, Serial Numbers: 560B102778, 560B102779, 560B102780, 560B102781, 560B102782, 560B102783, 560B102784, 560B102785, 560B102786, 560B102787, 560B102788, 560B102789, 560B102790, 560B102792, 560B102793, 560B102794, 560B102795, 560B102796, 560B102797, 560B102798, 560B102799, 560B102800, 560B102801, 560B102802, 560B102803, 560B102804, 560B102805, 560B102806, 560B102807, 560B102809, 560B102810, 560B102811, 560B102812, 560B102813, 560B102815, 560B102817, 560B102818, 560B102819, 560B102820, 560B102821, 560B102822, 560B102823, 560B102824, 560B102825, 560B102826, 560B102827, 560B102828, 560B102829, 560B102830, 560B102831, 560B102832, 560B102833, 560B102834, 560B102835, 560B102836, 560B102837, 560B102838, 560B102839, 560B102840, 560B102841, 560B102842, 560B102843, 560B102844, 560B102845, 560B102846, 560B102847, 560B102848, 560B102849, 560B102850, 560B102851, 560B102852, 560B102853, 560B102854, 560B102855, 560B102856, 560B102857, 560B102858, 560B102859, 560B102860, 560B102861, 560B102862, 560B102863, 560B102864, 560B102865, 560B102866, 560B102867, 560B102868, 560B102869, 560B102870, 560B102871, 560B102872, 560B102873, 560B102874, 560B102875, 560B102876, 560B102877, 560B102878, 560B102879, 560B102880, 560B102882, 560B102883, 560B102884, 560B102885, 560B102886, 560B102887, 560B102888, 560B102889, 560B102890, 560B102891, 560B102892, 560B102893, 560B102894, 560B102895, 560B102896, 560B102897, 560B102898, 560B102899, 560B102900, 560B102901, 560B102902, 560B102903, 560B102907, 560B102908, 560B102909, 560B102910, 560B102912, 560B102913, 560B102914, 560B102915, 560B102916, 560B102917, 560B102918, 560B102919, 560B102920, 560B102921, 560B102922, 560B102923, 560B102924, 560B102925, 560B102926, 560B102927, 560B102928, 560B102929, 560B102946, 560B102947, 560B102948, 560B102949, 560B102950, 560B102951, 560B102952, 560B102953, 560B102954, 560B102955, 560B102956, 560B102957, 560B102958, 560B102959, 560B102960, 560B102961, 560B102962, 560B102963, 560B102964, 560B102965, 560B102966, 560B102967, 560B102968, 560B102969, 560B102970, 560B102971, 560B102972, 560B102973, 560B102974, 560B102975, 560B102976, 560B102977, 560B102978, 560B102979, 560B102980, 560B102981, 560B102982, 560B102983, 560B102984, 560B102985, 560B102986, 560B102987, 560B102988, 560B102989, 560B102990, 560B102991, 560B102992, 560B102993, 560B102994, 560B102995, 560B102996, 560B102997, 560B102998, 560B102999, 560B103000, 560B103001, 560B103002, 560B103003, 560B103004, 560B103005, 560B103006, 560B103007, 560B103008, 560B103009, 560B103010, 560B103011, 560B103012, 560B103013, 560B103014, 560B103015, 560B103016, 560B103017, 560B103018, 560B103019, 560B103020, 560B103021, 560B103022, 560B103023, 560B103024, 560B103025, 560B103026, 560B103027, 560B103028, 560B103029, 560B103031, 560B103032, 560B103033, 560B103034, 560B103035, 560B103036, 560B103037, 560B103038, 560B103039, 560B103040, 560B103041, 560B103042, 560B103043, 560B103044, 560B103045, 560B103046, 560B103047, 560B103048, 560B103049, 560B103050, 560B103051, 560B103052, 560B103053, 560B103054, 560B103055, 560B103057, 560B103058, 560B103059, 560B103060, 560B103061, 560B103062, 560B103069, 560B103070, 560B103071, 560B103072, 560B103073, 560B103074, 560B103075, 560B103077, 560B103078, 560B103079 R560BCS1, GTIN 00643169315822, Serial Numbers: 560B102009, 560B102355, 560B102367

Why it was recalled

An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

Root cause (FDA determination)

Component change control

Action the firm took

In the United States (US), beginning 03-Mar-2021, a written Urgent Medical Device Correction letter was mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam

Timeline

Recall initiated: 2021-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186156. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.