Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

Reason: An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

Code information: serial numbers: 5K0005, 5K0006, 5K0007, 5K0009, 5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030, 5K0031, 5K0032, 5K0033, 5K0034, 5K0035, 5K0036, 5K0037, 5K0039, 5K0040, 5K0041, 5K0042, 5K0043, 5K0044, 5K0045, 5K0046, 5K0047, 5K0048, 5K0053, 5K0054, 5K0056, 5K0057, 5K0058, 5K0059, 5K0062, 5K0063, 5K0064, 5K0065, 5K0066, 5K0067, 5K0068, 5K0069, 5K0070, 5K0071, 5K0072, 5K0073, N5923, N5924, N5925, N5929, N5930, N5931, N5932, N5933, N6106, N6119, N6210, N6720, N7763, N7764, N7765, N7766, N7767, N7768, N7769, N7770, N7771, N7772, N7773, N7774, N7775, N7776, N7777, N7778, N7779, N7780, N7781, N7782, N7783, N7784, N7785, N7786, N7787, N8029, N8030, N8031, N8033, N8034, N8035, N8038, N8039, N8040, N8041, N8042, N8043, N8044, N8045, N8046, N8047, N8048, N8049, N8050, N8051, N8052, N8053, N8054, N8055, N8056, N8057, N8058, N8059, N8060, N8061, N8062, N8063, N8064, N8065, N8067, N8068, N8069, N8070, N8072, N8073, N8074.

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.