Recall Z-2777-2015
Medtronic Inc. Cardiac Rhythm Disease Management · initiated September 1, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Codes / lots: 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.
Reason for recall
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
FDA-determined cause: Component design/selection
Action taken
Medtronic began hand delivering an Urgent Medical Device Correction letter on September 1, 2015, to all affected customers. The letter described the issue. Customers were advised to continue using the device, per the operator's manual, and if a system notice appears, they are to carefully read and follow the instructions in the screen of the console. Medtronic personnel will track contact with the customer via Customer Contact Record. Customers with qeustions were instructed to contact their Medtronic AF Solutions representative. For questions regarding this recall call 1-877-464-2796 Technical Services.
Details
- Recall number
- Z-2777-2015
- Initiated
- September 1, 2015
- Posted by FDA
- September 17, 2015
- Terminated
- April 8, 2016
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 103 units
- Distribution
- 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.
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN