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Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 56...

FDA Device Recall #Z-1313-2021 — Class I — March 3, 2021

Recall Summary

Recall Number Z-1313-2021
Classification Class I — Serious risk
Date Initiated March 3, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Perfusion Systems
Location Brooklyn Park, MN
Product Type Devices
Quantity 387 devices (93 US)

Product Description

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

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.

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

Lot / Code Information

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

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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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