| Class 2 Device Recall Medtronic CryoConsole | |
Date Initiated by Firm | September 01, 2015 |
Date Posted | September 17, 2015 |
Recall Status1 |
Terminated 3 on April 08, 2016 |
Recall Number | Z-2777-2015 |
Recall Event ID |
72136 |
PMA Number | P020045 |
Product Classification |
Cardiac ablation percutaneous catheter - Product Code LPB
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Product | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K
For use in performing cardiac ablation procedures. |
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. |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Disease Management 8200 Coral Sea St NE Saint Paul MN 55112-4391
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For Additional Information Contact | 763-526-6000 |
Manufacturer 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 2 | Component design/selection |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LPB
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