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

Class I - Dangerous
🏥 Medical Devices Recalled: March 3, 2021 Medtronic Perfusion Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Perfusion Systems
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1313-2021

Related Recalls

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Medtronic Perfusion Systems

Class I - Dangerous

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

Oct 3, 2025 Infusion Pumps Nationwide View Details →