Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-2777-2015

Z-2777-2015 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

FDA device recall Z-2777-2015 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on September 1, 2015 and is designated Class II. Reason for recall: An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. The recall status is terminated (terminated April 8, 2016). Affected quantity: 103 units.

Recall Details

Product Type
Devices
Report Date
September 23, 2015
Initiation Date
September 1, 2015
Termination Date
April 8, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
103 units

Product Description

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

Reason for Recall

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

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.

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.

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

  • Z-0022-2016 Class II — Medtronic Medical Device Identification Card for SureScan pacemaker patients. (September 15, 2015)
  • Z-1365-2015 Class II — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx onl (March 23, 2015)
  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
  • Z-1276-2015 Class I — Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Se (February 23, 2015)
  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0997-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vent (January 30, 2014)
  • Z-1000-2014 Class II — Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Art (January 30, 2014)
  • Z-0999-2014 Class II — Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB787 (January 30, 2014)
  • Z-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)
  • Z-0996-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vent (January 30, 2014)

FDA data resources